FDA DeviceClass IINotable

FDA Recall: BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

Date: 2026-05-06
Brand: Becton Dickinson & Co.
Category: Medical Device
FDA Class: Class II

Description

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

Hazard

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

Remedy

2,200 units

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