Recall Weekly
Moderate riskFDA DeviceClass II

Medline C-Section Prep Convenience Kits recalled for sterility packaging breach risk

Medline's C-Section Prep Convenience Kits contain ChloraPrep and FREPP applicators with a potential sterility packaging breach due to wrinkles in the paper lid seal. If the sterile barrier is compromised, users may be exposed to microbial contamination. Health effects could range from no injury to localized infection, or in rare cases, serious infection requiring treatment or hospitalization.

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

What to do

  1. Check if you have affected lot numbers: 25BBG443, 25EBL829, 24EBR761, 24GBC622, 24GBX458, or 23LBT973.
  2. Do not use kits with these lot numbers.
  3. Contact your Medline representative or the FDA for return and replacement instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Sold in
Nationwide
Made for
Adults

This recall covers 16 products — see all of them.

Details

Units affected
352 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3060-2026

In the FDA's words

Description
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B 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) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25BBG443; 2) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25EBL829; 3) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24EBR761; 4) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBC622; 5) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBX458; 6) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 23LBT973 Distribution: US Nationwide distribution. Affected quantity: 352 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.

More from Medline

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device