Recall Z-3181-2026 ยท OFM Phlebotomy Blood Collection Kit
Medical Action Industries, Inc. 306
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
| Date | Sep 16, 2026 (initiated Jul 23, 2026) |
| Status | Open, Classified |
| Reason | Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection. |
| Root cause | Material/Component Contamination |
| Action | On 7/23/2026, correction notices were emailed to customers who were asked to do the following: 1) Identify, segregate, and quarantine all impacted product. 2) Discontinue use of the BD ChloraPrep Clear - 1 mL Applicators 3) Add warning labels to affected MAI kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other c |
| Quantity | 6,420 |
| Distribution | US Nationwide distribution in the states of OH, IN, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.