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: 8183
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medical Action Industries, Inc. 306
- Product
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of OH, IN, NC.
- Recall initiated
- 2026-07-23
- 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)
- Product quantity
- 6,420
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Arden
- State
- NC
- Country
- United States
- Event id
- 99628
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