Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml.
This recall has been terminated (originally issued May 25, 2006).
- Recall Initiated
- November 29, 2005
- Posted
- May 25, 2006
- Terminated
- December 5, 2006
- Recall Number
- Z-0906-06
- Quantity
- 218 units, each unit contains 5 bags.
- Firm Location
- Barcelona, CA Spain
- Official Source
- View on FDA website ↗
Reason for Recall
When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
Distribution
Distributed to health care facilities in California, Georgia and Oregon.
Lot / Code Info
FPB NEP, batch # X-003, code 722842.
Root Cause
Other
Action Taken
The consignees were notified by phone beginning November 11, 2005. They were requested to return the unused product in exchange for bags from other lot numbers. The returned product will be quarantined at the warehouse. All Gri-bags from batch X-003 will be destroyed.