Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles
Lot Codes / Batch Numbers
FPB NEP, batch # X-003, code 722842.
Products Sold
FPB NEP, batch # X-003, code 722842.
Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles is recalling Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter due to When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, IN, OR
Page updated: Jan 10, 2026