The Recall Desk
ModerateFDA (Devices)·Z-1558-2021·Announced 2021-05-19

Medical Action Industries Recalls Blood Culture Kits Due to Package Integrity Breach

Medical Action Industries is recalling 205 cases of Blood Culture Kits because a component may have a package integrity breach.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, but the source text explicitly states no illnesses or injuries are reported and the hazard is a potential package integrity breach. Per the rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3; however, given the specific nature of the defect (packaging integrity of a component) and lack of reported harm, it aligns with a moderate risk profile for a precautionary recall.

Plain-English summary

Medical Action Industries, Inc. is recalling 205 cases of Blood Culture Kits (MAI Kit Part Number: 80315D). The recall is due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

The affected kits were distributed nationwide to Ohio, Oregon, Florida, and California. The recall includes four specific lot numbers: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021). The UDI (GTIN) for the product is 20809160186074.

The source text does not specify any reported illnesses or injuries associated with this recall. Users should check their inventory for the specific lot numbers and expiration dates listed above.

The recalled product

Product
Kit: Blood Culture. MAI Kit Part Number: 80315D
Manufacturer
Medical Action Industries, Inc. 306
Category
Medical Device — Blood Culture Kits
Hazard

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 (6)

  • Kit Number: 80315D
  • UDI (GTIN): 20809160186074
  • Lot Number: 0000280007 (Expiration Date: 07/31/2021)
  • 0000280289 (Expiration Date: 06/30/2021)
  • 0000279599 (Expiration Date: 05/31/2021)
  • and 0000280554 (Expiration Date: 06/30/2021)

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Medical Action Industries, Inc. 306 under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Medical Action Industries, Inc. 306

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Same hazard · package integrity

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