—#173327

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.

FDA product code: OCT — Anti Fog Solution And Accessories, Endoscopy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K982465
Affected 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).

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Medline Industries, Inc. notified customers on about 05/30/2019 via "URGENT NOTICE: MEDICAL DEVICE RECALL ANTI-FOG SOLUTION" letter. Customers were instructed to examine inventory for the affected kit numbers and lot numbers, quarantine any affected kits, and affix the provided stickers on the affected kits advising to not use the Anti-Fog Solution components, discard any from the pack at point of use, and pull another approved product from the sterile supply. Single, sterile replacement product for the Anti-Fog Solution is available upon request. Customers were also instructed to complete and return the provided verification form listing the quantity of affected product on hand, even if it is none, and to also promptly notify any customers if the product was further distributed. Questions can be directed to Benjamin Gora at 1-866-359-1704.

Recalling firm

Firm: Medline Industries, Inc.
Address: 1170 S Northpoint Blvd, Waukegan, Illinois 60085-6757

Distribution

Distribution pattern: Nationwide distribution to AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, WY. Worldwide distribution to Canada and Malaysia.

Timeline

Recall initiated: 2019-05-30
Posted by FDA: 2019-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.