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Recall Observatory FDA recall evidence

Device product

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Z-1982-2026

April 07, 2026

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 98657
Status
Ongoing
Classification
Class II
Quantity
25,760 units
Official record key
device-enforcement:Z-1982-2026

Official wording

Reason: 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.

Code information: Catalog Nunber: 260684; UDI-DI: 30382902606841; Lot Numbers: 5303157, 5329857, 5329860.

Distribution pattern: Worldwide distribution - US Nationwide and the country of Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.