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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 Gambro see related information
Date Initiated by Firm July 18, 2014
Date Posted August 13, 2014
Recall Status1 Terminated 3 on February 05, 2015
Recall Number Z-2193-2014
Recall Event ID 68788
PMA Number P830063S006 
Product Classification Separator for therapeutic purposes, membrane automated blood cell/plasma - Product Code MDP
Product Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Code Information Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
Recalling Firm/
Manufacturer		 Gambro Renal Products, Incorporated
14143 Denver West Pkwy
Lakewood CO 80401-3266
For Additional Information Contact Thomas 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
Action Gambro 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 Commerce 401,451
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = MDP and Original Applicant = BAXTER INTERNATIONAL, INC.
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