Blood Culture Kits Recalled Due to Potential Sterile Barrier Compromise
Medical Action Industries is recalling blood culture kits containing BD ChloraPrep applicators with potentially compromised sterile seals, posing a risk of localized skin infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of localized skin or soft tissue infection without reported fatalities or systemic harm, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medical Action Industries, Inc. is recalling specific blood culture collection kits that contain BD ChloraPrep Clear 1 mL applicators. The affected products include the Blood Culture Collection Venipuncture Kit (REF: 77451), Blood Culture Kit (REF: 81834B), and Blood Culture Collection Kit (REF: 81834C). A total of 6,420 units were distributed nationwide in Ohio, Indiana, and North Carolina.
The recall is being conducted because an open or incomplete seal on the packaging of the applicator component may compromise the sterile barrier. If the product is used in this condition, it may lead to localized skin or soft tissue infection. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific kits should stop using them immediately. Users should check their inventory for the reference numbers and lot codes listed in the official recall notice to determine if they are affected.
The recalled product
- 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
- Manufacturer
- Medical Action Industries, Inc. 306
- Affected units
- 6,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
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