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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile I.V. bag

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 Class 2 Device Recall Sterile I.V. bagsee related information
Date Initiated by FirmNovember 29, 2005
Date PostedMay 25, 2006
Recall Status1 Terminated 3 on December 05, 2006
Recall NumberZ-0906-06
Recall Event ID 34243
510(K)NumberK033916 
Product Classification Container, I.V. - Product Code KPE
ProductGri-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.
Code Information FPB NEP, batch # X-003, code 722842.
FEI Number 3002807257
Recalling Firm/
Manufacturer		 Instituto Grifols, S.A.
#2 Can Guasch Street,
Poligono Levante
Parets Del Valles, Barcelona CA Spain 90032-3520
Manufacturer Reason
for Recall		When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce218 units, each unit contains 5 bags.
DistributionDistributed to health care facilities in California, Georgia and Oregon.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPE
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