Recall Z-2153-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
| Date | Jul 21, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | On June 12, 2025, firm instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No product is to be returned. |
| Quantity | 960 units |
| Distribution | Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.