Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834…
Medical Action Industries, Inc. 306 · 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 co…
Open FDA's page for this record- Cfres ID
- 222021
- Product res number
- Z-3181-2026
- Event date initiated
- 2026-07-23
- Event date posted
- 2026-09-16
- Recall status
- Open, Classified
- Res event number
- 99628
- Product code
- OFM
- Firm FEI number
- 1030451
- Recalling firm
- Medical Action Industries, Inc. 306
- Address 1
- 25 Heywood Rd
- City
- Arden
- State
- NC
- Postal code
- 28704-9302
- Additional info contact
- Marlene Jones 470-280-4277
- Root cause description
- Material/Component Contamination
- Product quantity
- 6,420
- Distribution pattern
- US Nationwide distribution in the states of OH, IN, NC.
- Product description
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
- Code info
77451/20809160195069/343602(5/31/2027), 349005(10/31/2027), 374030(11/30/2027), 375434(12/31/2027), 377632(4/2/2028), 327194(8/31/2026), 375105(3/31/2028), 336074(3/21/2027); 81834B/20809160403324/326214(7/31/2027); 81834C/20809160466602/347551(8/12/2026), 372502(8/10/2026), 374615(10/21/2026), 376461(10/23/2026), 377088(11/6/2026), 373129(9/3/2026), 374033(9/3/2026)
- 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.
- 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 GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.
- Harmonized identifiers (openFDA)
- Device name
- Phlebotomy Blood Collection Kit
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2750
- Device class
- 2
- Registration number
- 3004111573, 2321034, 9616088, 1030451, 3007329020, 1061124, 3004140833, 1825034, 1928237, 1123010, 3005012805, 1423537, 3007871198, 3035642068, 3013175547, 3013248161, 3009888344, 1643817
- FEI number
- 3004111573, 3007329020, 1030451, 1825034, 3004140833, 1928237, 3002902735, 1000512168, 3003399884, 3005012805, 3007871198, 3035642068, 3013175547, 3013248161, 3001236905, 3009888344, 1643817, 1000123297
