medical Class II Updated 2019-07-24

Medline Industries, Inc. recalls Anti-fog solution packaged in a Tyvek peel pouch and it is p

Recalled Product

Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.

Hazard / Issue

The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Fog solution Component Number: 80532/NONFB100B, Material Lot Number: 41186649M, 41186673M, 41211955M, 41186657M, 41236925M, 41186665M, 41102767M. Expiration Date 12/2020. Impacted Kit Number (Lot Number): DYNJ902840B (19CBW843), DYNJ904625B (19CBA697), DYNJ42835A (19CBA118), DYNJ39685A (19BBH495), DYNJ32935C (19BBE174), DYNJ36418F (19ABN461), DYNJ50765B (19BBJ183), DYNJ47704C (19BBE810), DYNJ0862775N (19CBA813), DYNJ43628A (19BBG651), CDS984674C (19CBA033), CDS984659K (19BBT877), CDS984656L (19ABO984), DYNJ0665310C (19CBG762), DYNJ42547B (19BBI339), DYNJ903659B (19BBT906), DYNJ903040C (19BBS351), DYNJ903038C (19CBB639), DYNJ54065 (19BBJ372), DYNJ900363G (19ABL752), DYNJ57609 (19ABN755), DYNJ903321J (19CBF179), DYNJ900357K (19BBU012), DYNJ904588 (19BBT976), CDS920126Y (19ABI371), DYNJ59847 (19ABN404), DYNJ22661K (19BBF049), DYNJ33545G (19ABI674), DYNJ26209L (19BBG751), DYNJ49882F (19ABN534), DYNJ903014C (19BBU011), CDS984155D (19BBD541), DYNJ904638A (19ABZ742), DYNJ59546 (19ABM642), DYNJ903012B (19ABI127), DYNJ43439B (19BBG181), DYNJ904605B (19ABX225), DYNJ902777C (19BBU748), DYNJ45036C (19BBH070), DYNJ0457880B (19BBD190), CDS760059F (19CBS256), DYNJ52677G (19ABM568), DYNJ37208B (19ABN372), DYNJ57108 (19BBH759), DYNJ27981L (19BBU534), DYNJ22708C (19CBI729), DYNJ42513B (19BBC527), DYNJ902659D (19DBC026), CDS984368A (19CBS618), CDS985100G (19BBU591), DYNJ902881A (19BBU615), DYNJ36733B (19BBT315), DYNJ902882B (19BBQ157), DYNJ56866A (19BBJ416), DYNJ43971 (19ABO971), CDS983055I (19BBD510), DYNJ24254D (19ABE952), DYNJ51727A (19BBJ776), DYNJ43160 (19BBE200), DYNJ59927 (19ABM565), CDS985356F (19CBH288), DYNJ50960D (19BBG937), DYNJ50594B (19BBC092), DYNJ59925 (19ABI682), CDS983771F (19BBS841), DYNJ903722F (19CBC482), DYNJ903688D (19BBN377), DYNJ901777M (19CBB415), DYNJ56696A (19BBT371), DYNJ904790B (19CBC724), DYNJ904826 (19BBA006), PHS628590008A (19BBG657), CDS982906K (19CBE109), DYNJ40736D (19ABE199), DYNJ32364F (19BBO433), DYNJ56626A (19BBI464), DYNJ43573A (19BBE169), CDS983900G (19CBE065), DYNJ901430F (19CBV052), DYNJ900760J (19CBA299), DYNJ36365B (19BBB942), DYNJ901160D (19ABH656), CDS860237V (19CBL702), DYNJ0618440D (19ABH894), DYNJ50543A (19ABI681), DYNJ0798129F (19BBD878), DYNJ31754C (19BBT585), DYNJ900723A (19DBF086), DYNJ900299D (19CBB300), DYNJ45576A (19BBU372), DYNJ53270B (19BBT500), DYNJ901822 (19BBA013), DYNJ24608F (19BBQ880), DYNJ41082F (19ABN865), DYNJ51144A (19ABM266), DYNJ50474B (19ABM212), DYNJ900298F (19CBD978), CDS981161W (19CBC564), DYNJ903906B (19CBM352), DYNJ904214A (19CBB908), DYNJ27440R (19BBG783), DYNJ57093 (19ABM639), DYNJ43427C (19ABM274), DYNJ55478B (19BBS313), DYNJ27430P (19BBE005), DYNJ53718A (19BBG277), DYNJ54690A (19BBC770), DYNJ901076F (19BBU036), DYNJ41531F (19BBJ347), DYNJ902165C (19BBR800), CDS983393I (19CBF160), DYNJ902188G (19ABY723), DYNJ903000D (19BBP501), DYNJ902172C (19ABL727), DYNJ902136F (19CBD684), DYNJ901868B (19BBU852), DYNJ30799D (19ABN506), DYNJ905003A (19CBK506), DYNJ56110 (19BBR129), DYNJ52016 (19BBU234), DYNJ57571 (19CBA099), CDS982234F (19ABZ502), DYNJ01910I (19ABU373), DYNJ45531C (19BBD198), DYNJ40156B (19CBA412), DYNJ20431K (19BBI165), DYNJ39810B (19ABI411), DYNJ35833C (19BBG604), DYNJ0705925D (19BBJ785), DYNJ00210K (19BBG066), DYNJ0567019U (19ABN489), DYNJ42420A (19ABO947), DYNJ48752A (19BBQ917), DYNJ58542A (19BBT963), CDS984007B (19BBR816), DYNJ47554B (19ABN648), DYNJ41789C (19ABN541), DYNJ41939A (19BBG785), DYNJ900787C (19CBS603), DYNJ46864 (19BBU487), DYNJS3024 (19ABL847), DYNJQ9044M (19BBS346), DYNJ33112G (19BBS717), DYNJ901674F (19BBS864), CDS984659K (19CBI752), DYNJ57609 (19CBA524), DYNJ905095 (19BBF351), DYNJ40064I (19BBF021), DYNJ905797 (19ABZ654), CDS981512D (19CBL323), DYNJ53067C (19ABA014), CDS985242D (19BBT180), DYNJ901501C (19BBI586), DYNJ901501C (19BBU616), DYNJ37208B (19BBG261), DYNJ60647 (19ABN834), DYNJ48601 (19BBG158), DYNJ57623 (19BBG755), DYNJ50746 (19ABM536), DYNJ48599 (19BBG561), DYNJ903514B (19CBA001), CDS983055I (19CBL202), DYNJ24254D (19CBA271), DYNJ50958C (19BBE201), DYNJQ0589J (19ABI633), DYNJQ0589J (19BBG274), DYNJ30954 (19ABR748), DYNJ33197G (19ABH728), DYNJ33197G (19BBI455), DYNJ902830B (19BBS834), DYNJ53409 (19BBI406), DYNJ53409 (18MB7934), DYNJ46488C (19BBC858), DYNJ56036A (19BBG377), DYNJ902250C (19BBS839), DYNJ904826 (19BBN793), DYNJ904826 (19BBR431), CDS982906K (19CBI565), DYNJ902546G (19ABX896), DYNJ48431B (19ABJ347), DYNJ901210D (19CBK476), DYNJ901210D (19EBB837), DYNJ30988C (19ABN378), DYNJ30988C (19BBT617), DYNJ41365D (19BBG190), DYNJ39406A (19ABN416), DYNJ56004 (19CBA327), DYNJ901160D (19BBS792), DYNJ50052A (19BBJ218), DYNJ60067 (19BBG907), DYNJ903254A (19BBD540), DYNJ903254A (19CBG054), CDS981537D (19CBA526), DYNJ49351 (19BBJ114), DYNJ40981F (19BBG606), DYNJ43869I (19ABE918), DYNJ33189 (19BBE839), DYNJ46962F (19CBA778), DYNJ53650B (19ABJ753), DYNJ02309C (19BBG760), DYNJ49558B (19BBB744), DYNJ39666D (19BBI360), DYNJ55323B (19BBQ851), DYNJ901330C (19ABX749), DYNJ51195C (19ABM930), DYNJ41630B (19BBG910), CDS984769D (19CBM279), DYNJ902188G (19CBR545), DYNJ902188G (19DBM497), DYNJ39458G (19ABO674), DYNJ45498A (19ABM460), DYNJ35671A (19ABM918), DYNJ39304B (19ABO289), DYNJ54966 (19BBB884), DYNJ57583 (19BBG432), DYNJ53992A (19BBC971), CDS985035I (19CBB959), DYNJ01910I (19BBG799), DYNJ45664A (19BBG315), DYNJ45806C (19ABN758), DYNJ42117 (19CBA827), DYNJ21888N (19BBE998), DYNJ37358D (19BBT664), DYNJ56957B (19BBF044), DYNJ54675A (18LBM107), DYNJ52468 (18KBR226), CDS985025C (19BBE399), CDS985025C (19CBA021), SYNJ10073C (19BBE680), DYNJ20431K (19CBA470), CDS983989C (19BBM834), DYNJ900787C (19BBF368), DYNJHTLP01 (19BBC630).
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