FDAClass IMay 19, 2021

Kit: Midline Insertion DA. MAI Kit recall

Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Why was Kit: Midline Insertion DA. 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: 77981B; UDI (GTIN): 20809160284053; Lot Number: 0000281502 (Expiration Date: 04/08/2022), 0000282039 (Expiration Date: 04/08/2022), 0000274390 (Expiration Date: 07/09/2021), and 0000279101 (Expiration Date: 11/13/2021)

Product
Kit: Midline Insertion DA. MAI Kit Part Number: 77981B
Recalling firm
Medical Action Industries, Inc. 306
Quantity
110 cases (5 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)
Open FDA enforcement record Latest recalls