Medline Convenience Kits Recalled for Potential Sterility Breach
Medline Industries is recalling 58,037 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a risk of harm (infection) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 58,037 Medline Convenience Kits distributed nationwide. The affected kits contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators. The recall is due to a potential breach of sterility in the packaging, 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 range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening.
The recall includes specific catalog numbers and lot numbers, including DYKM1414, DYNDH1462A, DYNJ38145F, and DYNJ63199A. Users should check their inventory against the provided lot numbers and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 58,037
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) DYKM1414
- UDI-DI: 10889942481293(each)
- 40889942481294(case)
- Lot Number: 25BBB327
- 2) DYKM1414
- Lot Number: 24KBE261
- 3) DYNDH1462A
- UDI-DI: 10193489993424(each)
- 40193489993425(case)
- Lot Number: 24ABC301
- 4) DYNDH1462A
- Lot Number: 24ABT704
- 5) DYNDH1462A
- Lot Number: 24BBO246
- 6) DYNDH1462A
- Lot Number: 24BBU663
- 7) DYNDH1462A
- Lot Number: 24CBJ141
- 8) DYNDH1462A
- Lot Number: 23JBH263
Distribution
Distributed nationwide across the United States.
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