Medline Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 4,636 convenience kits nationwide due to packaging wrinkles that may compromise sterility, posing a risk of microbial contamination.
What this means for you
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 FDA classified this as a Class II recall. The hazard involves a risk of harm (microbial contamination and infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medline Industries, LP is recalling 4,636 convenience kits distributed nationwide. The recall involves specific catalog numbers including CDS840396X, CDS840396Y, CDS983348AA, CDS983348AB, CDS983672O, CDS983672P, DYKM1982, DYNDA1080, DYNJ67490C, DYNJ907400D, and DYNJ908990A. The 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. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences include no injury, localized infection, or more serious infection 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 FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog N
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 4,636
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) CDS840396X
- UDI-DI: 10193489461916(each)
- 40193489461917(case)
- Lot Number: 24ABC933
- 2) CDS840396X
- Lot Number: 24ABK089
- 3) CDS840396X
- Lot Number: 24ABL893
- 4) CDS840396Y
- UDI-DI: 10195327574932(each)
- 40195327574933(case)
- Lot Number: 25BBG163
- 5) CDS840396Y
- Lot Number: 24KBK977
- 6) CDS840396Y
- Lot Number: 24BBO585
- 7) CDS840396Y
- Lot Number: 24CBR417
- 8) CDS840396Y
- Lot Number: 24FBS930
Distribution
Distributed nationwide across the United States.
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