Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Why it was recalled
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
1) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25ABK513; 2) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25DBM841; 3) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25EBU475; 4) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25FBQ817; 5) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25HBK086; 6) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23LBV280; 7) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24BBN930; 8) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBK663; 9) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBS890; 10) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24FBH870; 11) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24GBR415; 12) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24HBK593; 13) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBE456; 14) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBN932; 15) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23KBQ478; 16) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25DLA351; 17) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25ELA624; 18) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24BLA086; 19) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24CLA271; 20) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24DLA466; 21) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24FLA328; 22) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24GLA526; 23) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23JLB277; 24) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23KLB020 — 3752 kits
Record details
Medline Industries, LP — US Nationwide distribution.