Medline C-Section Prep Kits Recalled for Potential Sterility Breach
Medline is recalling 352 C-Section Prep kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening, which aligns with the rubric criteria for a Severe (Score 4) classification involving significant injury or hospitalization reports.
Plain-English summary
Medline Industries, LP is recalling 352 units of C-Section Prep Convenience Kits (Model Number DYNJ32702B) distributed nationwide in the United States. The recall involves specific lots identified by UDI-DI 10193489431070 and 40193489431071, with lot numbers 25BBG443, 25EBL829, 24EBR761, 24GBC622, 24GBX458, and 23LBT973.
The recall is due to a potential breach of sterility in the packaging of the BD ChloraPrep Clear and FREPP Clear applicators included in the kits. Wrinkles in the paper lidding may extend to the seal area, potentially compromising the sterile barrier. If the barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, or hospitalization. In rare cases, severe infection could become life-threatening, particularly for critically ill or immunocompromised patients. Consumers and healthcare providers should check their inventory for the affected model and lot numbers and stop using these kits if they match the recalled description.
The recalled product
- Product
- Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
- Manufacturer
- Medline Industries, LP
- Affected units
- 352
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 1) DYNJ32702B
- UDI-DI: 10193489431070(each)
- 40193489431071(case)
- Lot Number: 25BBG443
- 2) DYNJ32702B
- Lot Number: 25EBL829
- 3) DYNJ32702B
- Lot Number: 24EBR761
- 4) DYNJ32702B
- Lot Number: 24GBC622
- 5) DYNJ32702B
- Lot Number: 24GBX458
- 6) DYNJ32702B
- Lot Number: 23LBT973
Distribution
Distributed nationwide across the United States.
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