Device product
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Z-1982-2026
Product summary
- 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
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.