Kit: LVAD Dres Chg. MAI Kit recall
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Why was Kit: LVAD Dres Chg. MAI Kit recalled?
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)
- Product
- Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 10 cases (20 kits per case)
- Distribution
- Distributed US nationwide to OH, OR, FL and CA.
- Recall date
- May 19, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)