MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25DMC189; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMH655; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMC735; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24KMA168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24IMD969; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24GMF018; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24EMA387; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23LBR964; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23KBR832; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23JBE549; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21LME546; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21KMG048; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21JMH240; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21IMC541; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21GMD231; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21DME148; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21CMC690; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25HBB990; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25FBO533; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25EBA604; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25CBB580; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25ABE166; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24IBR571; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBU707; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBA096; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24DBC284; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24CBF095; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24BBA310; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24ABM210; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21DBB421; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21BBO116; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21GBR980; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21GBR981; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21DBR243; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21BBB699; Medline Kit Number/SKU DYNJ41314B: UDI/DI 10198459572173 (each), 40198459572174 (case), Lot Number 26ABW138; Medline Kit Number/SKU DYNJ41314B: UDI/DI 10198459572173 (each), 40198459572174 (case), Lot Number 25LBT658; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23JBH935; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23HBM023; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23HBA226; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23GBG856; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23FBD345; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23EBD455; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 23BBN023; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22KBC161; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22JBL911; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22IBR338; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22HBE563; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22GBB332; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22DBN951; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 22BBT782; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 21LBM798; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 21VBD256; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 21IBH631; Medline Kit Number/SKU DYNJ67159: UDI/DI 10193489421637 (each), 40193489421638 (case), Lot Number 21FBD506; Medline Kit Number/SKU DYNJ67159B: UDI/DI 10195327585716 (each), 40195327585717 (case), Lot Number 24ABN500; Medline Kit Number/SKU DYNJ67159B: UDI/DI 10195327585716 (each), 40195327585717 (case), Lot Number 24ABG172; Medline Kit Number/SKU DYNJ67159C: UDI/DI 10195327669423 (each), 40195327669424 (case), Lot Number 24JBW695; Medline Kit Number/SKU DYNJ67159C: UDI/DI 10195327669423 (each), 40195327669424 (case), Lot Number 24JBA856; Medline Kit Number/SKU DYNJ67159C: UDI/DI 10195327669423 (each), 40195327669424 (case), Lot Number 24GBY089; Medline Kit Number/SKU DYNJ67159C: UDI/DI 10195327669423 (each), 40195327669424 (case), Lot Number 24EBD720; Medline Kit Number/SKU DYNJ67159C: UDI/DI 10195327669423 (each), 40195327669424 (case), Lot Number 24DBG026; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 26BBH393; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 25LBL862; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 25JBK760; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 25HBK215; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 25FBJ199; Medline Kit Number/SKU DYNJ67159D: UDI/DI 10198459294143 (each), 40198459294144 (case), Lot Number 25DBB533; Medline Kit Number/SKU DYNJT6852: UDI/DI 10198459583513 (each), 40198459583514 (case), Lot Number 26BBT868; Medline Kit Number/SKU DYNJT6852: UDI/DI 10198459583513 (each), 40198459583514 (case), Lot Number 25KBL900; Medline Kit Number/SKU DYNJ82901B: UDI/DI 10198459437335 (each), 40198459437336 (case), Lot Number 25KMI697; Medline Kit Number/SKU DYNJ82901B: UDI/DI 10198459437335 (each), 40198459437336 (case), Lot Number 25KMH448; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 23CBH486; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 23ABL372; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22JBD064; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22GBZ380; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22FBS118; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22CBX023; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22ABU279; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 22ABG172; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21LBS917; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21JBW610; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21JBF070; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21FBJ399; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21EBP668; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21BBJ995; Medline Kit Number/SKU DYNJ34432J: UDI/DI 10193489404456 (each), 40193489404457 (case), Lot Number 21ABA353; Medline Kit Number/SKU DYNJ34432K: UDI/DI 10195327384401 (each), 40195327384402 (case), Lot Number 23HBB977; Medline Kit Number/SKU DYNJ34432K: UDI/DI 10195327384401 (each), 40195327384402 (case), Lot Number 23GBC923; Medline Kit Number/SKU DYNJ34432K: UDI/DI 10195327384401 (each), 40195327384402 (case), Lot Number 23EBJ509; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24JBM566; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24IBD224; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24HBA058; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24GBB789; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24EBJ806; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24DBT403; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24DBF904; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 24BBQ443; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 23LBQ471; Medline Kit Number/SKU DYNJ34432L: UDI/DI 10195327511654 (each), 40195327511655 (case), Lot Number 23KBU644; Medline Kit Number/SKU DYNJ906947: UDI/DI 10193489299731 (each), 40193489299732 (case), Lot Number 22OBC517; Medline Kit Number/SKU DYNJ906947: UDI/DI 10193489299731 (each), 40193489299732 (case), Lot Number 22CBW739; Medline Kit Number/SKU DYNJ906947: UDI/DI 10193489299731 (each), 40193489299732 (case), Lot Number 22ABC151; Medline Kit Number/SKU DYNJ906947A: UDI/DI 10195327128296 (each), 40195327128297 (case), Lot Number 23DBE955; Medline Kit Number/SKU DYNJ906947A: UDI/DI 10195327128296 (each), 40195327128297 (case), Lot Number 23ABP498; Medline Kit Number/SKU DYNJ906947A: UDI/DI 10195327128296 (each), 40195327128297 (case), Lot Number 22HBH329; Medline Kit Number/SKU DYNJ906947A: UDI/DI 10195327128296 (each), 40195327128297 (case), Lot Number 22FBM732; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23LBK760; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23LBF829; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23KBW900; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23JBI914; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23HBG246; Medline Kit Number/SKU DYNJ906947B: UDI/DI 10195327380984 (each), 40195327380985 (case), Lot Number 23EBU035; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24JBK865; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24JBA344; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24IBN106; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24GBR916; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24GBK603; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24FBI305; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24EBD043; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24DBD823; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24CBB548; Medline Kit Number/SKU DYNJ906947C: UDI/DI 10195327569006 (each), 40195327569007 (case), Lot Number 24BBL769; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25JBU960; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25JBD859; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25GBW571; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25GBM727; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25EBR822; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25CBL210; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25ABN213; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 25ABD653; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 24LBD925; Medline Kit Number/SKU DYNJ906947D: UDI/DI 10198459156892 (each), 40198459156893 (case), Lot Number 24KBU887; Medline Kit Number/SKU DYNJ912132: UDI/DI 10198459639593 (each), 40198459639594 (case), Lot Number 26CBB112; Medline Kit Number/SKU DYNJ912132: UDI/DI 10198459639593 (each), 40198459639594 (case), Lot Number 26ABO288; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25LMC038; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25LMA314; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25IMI321; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25HMA488; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25FMC285; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25DMG929; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25CMG346; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 25BMB083; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 24LME935; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 24JMB664; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 24HMD395; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 24EME998; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 24BMI128; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 23LMG888; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 23GMI303; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 23FMD541; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 23EMD600; Medline Kit Number/SKU CDS983579J: UDI/DI 10195327295387 (each), 40195327295388 (case), Lot Number 23DMH786; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 23JBC180; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 23IBM022; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 23CBT642; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 23ABU424; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 23ABE617; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22LBM285; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22LBL299; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22LBC398; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22KBI115; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22JBM360; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22HBW123; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22EBU168; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22NBF154; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 22NBD200; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 21KBA484; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 21IBJ325; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 21IBC193; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 21FBF895; Medline Kit Number/SKU CDS983911J: UDI/DI 10193489402667 (each), 40193489402668 (case), Lot Number 21FBF898; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25JBE929; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25JBF476; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25GBW710; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25EBN090; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25CBQ682; Medline Kit Number/SKU CDS983911L: UDI/DI 10198459238208 (each), 40198459238209 (case), Lot Number 25BBK668; Medline Kit Number/SKU DYNJ65924D: UDI/DI 10198459177200 (each), 40198459177201 (case), Lot Number 25DBH769; Medline Kit Number/SKU DYNJ65924D: UDI/DI 10198459177200 (each), 40198459177201 (case), Lot Number 24KBL400; Medline Kit Number/SKU DYNJ65924F: UDI/DI 10198459475993 (each), 40198459475994 (case), Lot Number 26DBE515; Medline Kit Number/SKU DYNJ65924F: UDI/DI 10198459475993 (each), 40198459475994 (case), Lot Number 26CBJ573; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22LBC989; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22GBJ158; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22FBG763; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22EBC244; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22EBA136; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22ABS158; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 22ABC145; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 21IBV683; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 21GBM229; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 21EBO675; Medline Kit Number/SKU DYNJ900273D: UDI/DI 10888277759534 (each), 40888277759535 (case), Lot Number 21ABD425; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 25JBK123; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 25GBV261; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 25GBC113; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 25BBN516; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 25ABC632; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24KBD011; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24IBT024; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24IBE080; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24HBP714; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24FBL611; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24BBV258; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 24BBO683; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23LBT922; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23LBM669; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23IBC933; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23IBD125; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23HBC371; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23GBB272; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23EBN120; Medline Kit Number/SKU DYNJ900273F: UDI/DI 10195327348205 (each), 40195327348206 (case), Lot Number 23CBL737; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23KMI895; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23KMD181; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23GMF223; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23EMF755; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23CMF122; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23CMB203; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23BMH561; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23BMF867; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 23BMB770; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22LMC186; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22JMH127; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22HMF508; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22GME420; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22EMF689; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22CMG452; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 22AMF650; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21KMH512; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21JMB022; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21GMD813; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21FMF915; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21FMF059; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21DKA276; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21CKA260; Medline Kit Number/SKU CDS984596F: UDI/DI 10193489484649 (each), 40193489484640 (case), Lot Number 21BKA125; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 26DBC220; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 26BBH093; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 26ABQ164; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25KBQ260; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25HBS223; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25CBU691; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25BBO684; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25BBD033; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 25ABI075; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24LBD957; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24JBN479; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24IBI110; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24EBN280; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24CBG271; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24BBB062; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 24BBB068; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 23LBI203; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 23HBD159; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 23ABP326; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 23ABP470; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22KBM274; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22IBA124; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22HBF411; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22FBO642; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22DBG492; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22BBV242; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 22BBM416; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 21JBU176; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 21IBD412; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 21HBO756; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 21GBH376; Medline Kit Number/SKU CDS985201A: UDI/DI 10889942942312 (each), 40889942942313 (case), Lot Number 21CBT396; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 25HBI452; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 25FBT604; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 25DBR483; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 25CBK782; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 25ABP633; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24KBU153; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24KBF638; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24IBD754; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24HBA458; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24GBH767; Medline Kit Number/SKU CDS982891F: UDI/DI 10889942216956 (each), 40889942216957 (case), Lot Number 24FBN482; Medline Kit Number/SKU CDS982891F: UDI/
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.