FDA Medical Device Recalls (openFDA)
Instituto Grifols, S.A.: 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 number
- Z-0906-06
- Recalling firm
- Instituto Grifols, S.A.
- 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.
- Status
- Terminated
- Initiated
- 2005-11-29
- Posted
- 2006-05-25
- Terminated
- 2006-12-05
- Reason
- When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
- Root cause
- Other
- Action
- 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.
- Quantity
- 218 units, each unit contains 5 bags.
- Distribution
- Distributed to health care facilities in California, Georgia and Oregon.
- Lot, serial or model codes
- FPB NEP, batch # X-003, code 722842.
- 510(k) numbers
- ["K033916"]
- PMA numbers
- not on file
- Product code
- KPE
- Firm FEI
- 3002807257
- Firm city
- Parets Del Valles Barcelona
- Firm state
- CA
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28