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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer H.A.S. Autotransfusion System Replacement Kit

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  Class 2 Device Recall Zimmer H.A.S. Autotransfusion System Replacement Kit see related information
Date Initiated by Firm January 29, 2008
Date Posting Updated September 19, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1483-2008
Recall Event ID 47233
510(K)Number K9202273  
Product Classification autotranfusion apparatus - Product Code CAC
Product Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.
Code Information All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-365-3793
Manufacturer Reason
for Recall
The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
FDA Determined
Cause 2
Packaging process control
Action Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.
Distribution Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
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.
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