Recall Z-0906-06 ยท KPE Container, I.V.
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.
| Date | May 25, 2006 (initiated Nov 29, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033916 | GRI-BAG, GRI-BAG AP Laboratorios Grifols, S.A., Dec 30, 2003 |