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U.S. Department of Health and Human Services

Class 2 Device Recall Gambro

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 Class 2 Device Recall Gambrosee related information
Date Initiated by FirmJuly 18, 2014
Date PostedAugust 13, 2014
Recall Status1 Terminated 3 on February 05, 2015
Recall NumberZ-2200-2014
Recall Event ID 68788
510(K)NumberK011221 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductPrisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Code Information Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015
Recalling Firm/
Manufacturer		 Gambro Renal Products, Incorporated
14143 Denver West Pkwy
Lakewood CO 80401-3266
For Additional Information ContactThomas W. Dielmann
303-232-6800
Manufacturer Reason
for Recall		Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
FDA Determined
Cause 2		Device Design
ActionGambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.
Quantity in Commerce401,451
DistributionWorldwide Distribution.
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 = KDI
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