Official recall notice
FDA DeviceClass IINotable
FDA Recall: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
- Recall date
- 2026-05-06
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
25,760 units
Product 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.