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FDA (Device enforcement)Recalled 2021-04-09closedclass i

Medical Action Industries, Inc. 306: Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

Is my product affected?

Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

  • UPC 20809160247775

Check against the official notice below — it lists the full affected range.

What happened

Medical Action Industries, Inc. is recalling its 306 Central Line Dressing Change Clear Sequence Kit (Part Number 79420) due to potential package integrity breaches in the BD ChloraPrep 3mL applicator component included in the kits. The recall affects 30 cases containing 20 kits per case that were distributed nationwide to Ohio, Oregon, Florida, and California.

The affected kits have UDI (GTIN) number 20809160247775 and one of three lot numbers: 0000276767 (expiration date 01/31/2022), 0000278361 (expiration date 05/31/2022), or 0000281458 (expiration date 08/31/2022). The source document does not specify a remedy or what consumers should do with recalled kits.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Details from the source

Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Distribution: Distributed US nationwide to OH, OR, FL and CA. Quantity: 30 cases (20 kits per case) Lot/code info: 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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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