Medline Convenience Kits — Class II medical device recall Z-2153-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-07-30, distributed in CA, FL, PA, TX. Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to pot
| Recall number | Z-2153-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-06-12 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Distributed | CA, FL, PA, TX |
| Quantity | 960 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10889942754571, 40889942754572 |
| Lot numbers | 24EBR566 |
| Model numbers | DYKM1564 |
Product
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Reason for recall
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2153-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.