FDA DeviceClass IINotable
FDA Recall: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
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
25,760 units
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