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.
FDA Recall Z-0906-06 · Posted 2006-05-25
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Recalling FirmInstituto Grifols, S.A.
Recall StatusTerminated
Product CodeKPE
Date Initiated2005-11-29
Date Terminated2006-12-05
Product Quantity218 units, each unit contains 5 bags.
Reason for Recall
When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
Firm 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.
Root Cause
Other
Distribution Pattern
Distributed to health care facilities in California, Georgia and Oregon.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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