Medline Convenience Kits with BD ChloraPrep recalled due to sterility breach risk
Medline Convenience Kits containing BD ChloraPrep applicators are being recalled due to potential open seals that could breach sterility and increase infection risk. The recall affects 960 units distributed in California, Florida, Pennsylvania, and Texas.
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: This is an FDA Class II medical device recall involving confirmed packaging defects (potential open seals) that could breach sterility with risk of infection. As no illnesses or injuries have been reported to date, it meets the High severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Convenience Kits (LABOR TRIAGE KIT, REF DYKM1564) that contain BD ChloraPrep Clear - 1 mL Applicators due to potential open seals in the packaging that could compromise sterility.
The recall affects 960 units with lot number 24EBR566 distributed to California, Florida, Pennsylvania, and Texas. A breach in sterility may result in infection-related harms for patients using the affected kits.
Healthcare facilities and users of these products should stop using the recalled units immediately and contact Medline Industries for further guidance.
The recalled product
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- infection-risk
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 (3)
- UDI/DI 10889942754571 (EA)
- 40889942754572 (CASE)
- Lot Numbers: 24EBR566
Distribution
Distribution scope not specified by the agency.
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