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
FDA Recall Z-3181-2026 · Posted 2026-09-16
Advertisement
Recalling FirmMedical Action Industries, Inc. 306
Recall StatusOpen, Classified
Product CodeOFM
Date Initiated2026-07-23
Product Quantity6,420
Reason for Recall
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.
Firm 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 critical product information found on existing product labeling.
4) Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.
5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.
6) Complete and return Recall Response Form via email to [email protected]
Report any quality problems or adverse events associated with the products listed in this notification to [email protected].
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide distribution in the states of OH, IN, NC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement