The Recall Desk
ModerateFDA (Devices)·Z-1555-2021·Announced 2021-05-19

Medical Action Industries Recalls Injection Kits Due to Package Integrity Breach

Medical Action Industries is recalling 180 Injection REVIEW MAI 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, which typically indicates a low probability of adverse health consequences, and the hazard is a potential package integrity breach without reported injuries.

Plain-English summary

Medical Action Industries, Inc. is recalling 9 cases (180 kits total) of the Injection REVIEW MAI Kit, Part Number 74736. The recall is due to a potential breach in the package integrity of a component, specifically the BD ChloraPrep 3mL applicator.

The affected kits have the UDI (GTIN) 20809160023720 and Lot Number 0000266521, with an expiration date of 02/28/2022. The products were distributed nationwide to Ohio, Oregon, Florida, and California.

Consumers and healthcare facilities should stop using the affected kits and contact Medical Action Industries, Inc. for further instructions or a replacement.

The recalled product

Product
Kit: Injection REVIEW MAI Kit Part Number: 74736

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 (3)

  • Kit Number: 74736
  • UDI (GTIN): 20809160023720
  • Lot Number: 0000266521 (Expiration Date: 02/28/2022)

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 →