Recall Z-2155-2025 ยท OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
| 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 | 15700 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.