Medical Action Industries Recalls LVAD Dressing Change Kits Due to Package Integrity
Medical Action Industries is recalling LVAD Dressing Change Kits because a component may have a package integrity breach.
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 FDA classified this as a Class I recall, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Medical Action Industries, Inc. is recalling the LVAD Dressing Change MAI Kit (Part Number 79544B). The recall is due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
The affected product consists of 10 cases, with 20 kits per case. The kits were distributed nationwide to Ohio, Oregon, Florida, and California. The specific lot number is 0000282089, with an expiration date of 02/12/2022.
The FDA has classified this as a Class I recall. Consumers and healthcare providers should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — Surgical Kits
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: 79544B
- UDI (GTIN): 20809160341855
- Lot Number: 0000282089 (Expiration Date: 02/12/2022)
Distribution
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
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