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 DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
✅ 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.