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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = MDP
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