Device recall
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
- Recall number
- Z-3181-2026
- Event id
- 99628
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medical Action Industries, Inc. 306
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 23, 2026
- Center classification date
- Sep 16, 2026
- Product code
- OFM
- Device type
- Phlebotomy Blood Collection Kit
- 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
- Quantity
- 6,420
- 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)
- Distribution
- US Nationwide distribution in the states of OH, IN, NC.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Arden, NC, United States