Anti-fog solution recall: Impurity Out of Spec

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

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…

Recalling firm

Medline Industries, Inc.

Quantity

14,550 units

Distribution

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.

Recall date

July 24, 2019

Classification

Class II

Status

Ongoing

Agency

FDA (device)