Medline Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 18,290 convenience kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly mentions potential hospitalization and life-threatening infections, which aligns with the 'Severe' criteria for FDA Class II recalls with hospitalization reports.
Plain-English summary
Medline Industries, LP is recalling 18,290 convenience kits, including the Ortho Aspiration Kit, Should Block Kit, and Trima Kit. These kits contain BD ChloraPrep Clear and FREPP Clear applicators that have a potential breach of sterility in the packaging. The issue is caused by wrinkles in the paper lidding that may extend to the seal area.
If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences include no injury, localized infection, or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, severe infection could become life-threatening, particularly in critically ill or immunocompromised patients.
The affected kits were distributed nationwide in the United States. Consumers and healthcare facilities should check their inventory for the specific model numbers and lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 18,290
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 (20)
- 1) DYKM1636A
- UDI-DI: 10889942925858(each)
- 40889942925859(case)
- Lot Number: 25ABW688
- 2) DYKM1636A
- Lot Number: 23LBT438
- 3) DYKM1881A
- UDI-DI: 10198459025174(each)
- 40198459025175(case)
- Lot Number: 24KBS611
- 4) DYNDB3077C
- UDI-DI: 10193489273809(each)
- 40193489273800(case)
- Lot Number: 25BBB106
- 5) DYNDB3077C
- Lot Number: 24KBJ751
- 6) DYNDB3077C
- Lot Number: 24LBO630
- 7) DYNDB3077C
- Lot Number: 24ABB622
Distribution
Distributed nationwide across the United States.
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