BD GasPak EZ CO2 Pouch System gas generating sachets underperforming
Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall affecting a laboratory diagnostic device with no reported illnesses or injuries. The hazard is performance-related (sub-specification gas production) rather than a direct safety threat, making it consistent with a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems for microbiologic use. The affected Catalog Number is 260684 (UDI-DI: 30382902606841), with Lot Numbers 5303157, 5329857, and 5329860. BD identified that gas generating sachets in these lots may produce carbon dioxide levels below specification, which could affect their intended laboratory use.
Approximately 25,760 units have been distributed worldwide, including throughout the US and to Hong Kong. These systems are used for microbiologic applications where precise gas composition is required for accurate laboratory results.
Healthcare facilities and laboratories using affected lots should discontinue use and contact Becton Dickinson with questions. Customers should refer to FDA Medical Device Recall Z-1982-2026 for further information.
The recalled product
- Product
- BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- performance-defect
- gas-generation-below-spec
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Nunber: 260684
- UDI-DI: 30382902606841
- Lot Numbers: 5303157
- 5329857
- 5329860.
Distribution
Distributed nationwide across the United States.
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