Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied ste
FDA device recall Z-0906-06 · posted 2006-05-25 · Terminated
Recall details
- Recalling firm
- Instituto Grifols, S.A.
- Reason for recall
- When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPE
- Quantity affected
- 218 units, each unit contains 5 bags.
- Distribution
- Distributed to health care facilities in California, Georgia and Oregon.
- Date initiated
- 2005-11-29
- Date posted
- 2006-05-25
- Date terminated
- 2006-12-05
- Location
- Parets Del Valles Barcelona, CA, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRI-BAG, GRI-BAG AP (K033916) | Laboratorios Grifols, S.A. | 2003-12-30 |