Recall Weekly
Moderate riskFDA DeviceClass II

Medline Convenience Kits recalled for potential sterility breach in ChloraPrep and FREPP applicators

Medline's Labor CDS and Vaginal Delivery Admission Bag kits contain ChloraPrep and FREPP applicators with wrinkled packaging that may compromise the sterile barrier. If the seal is breached, patients and healthcare workers may be exposed to microbial contamination, ranging from no injury to serious infection requiring treatment.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if your facility has received affected kits (see lot numbers in the original notice).
  2. Do not use affected kits; quarantine and return them to Medline.
  3. Contact Medline or the FDA MedWatch program if kits were already used in patient care.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Sold in
Nationwide
Made for
Adults

This recall covers 16 products — see all of them.

Details

Units affected
3752 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3059-2026

In the FDA's words

Description
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F 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. 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 Distribution: US Nationwide distribution. Affected quantity: 3752 kits
Hazard
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.

16 products in this recall

Medline convenience kits recalled for possible sterility breach

Medline is recalling 16 convenience kit products that contain BD ChloraPrep Clear or FREPP Clear antiseptic applicators. Wrinkles in the paper lidding may extend to the seal, which could break the sterile packaging and allow microbial contamination. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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