| Class 2 Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 3/16" Drain | |
Date Initiated by Firm | January 29, 2008 |
Date Posted | September 19, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number | Z-1481-2008 |
Recall Event ID |
47233 |
Product Classification |
autotranfusion apparatus - Product Code CAC
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Product | Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16"
Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-030-05. |
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
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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 |
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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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