The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1554-2021·Announced 2021-05-19

Medical Action Industries Recalls Central Line Dressing Change Kits

Medical Action Industries is recalling Central Line Dressing Change Kits due to a potential breach in the package integrity of a component.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator."

Plain-English summary

Medical Action Industries, Inc. is recalling Central Line Dressing Change Kits (Part Number 79420) due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

The recall involves 30 cases, with 20 kits per case. The affected kits were distributed nationwide to Ohio, Oregon, Florida, and California. Specific lot numbers affected are 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022).

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected kits. The UDI (GTIN) for the product is 20809160247775.

The recalled product

Product
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Manufacturer
Medical Action Industries, Inc. 306
Category
Medical Device — Surgical 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 (5)

  • Kit Number: 79420
  • UDI (GTIN): 20809160247775
  • Lot Number: 0000276767 (Expiration Date: 01/31/2022)
  • 0000278361 (Expiration Date: 05/31/2022)
  • and 0000281458 (Expiration Date: 08/31/2022)

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 →

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