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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain

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 Class 2 Recall
Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain
see related information
Date Posted September 19, 2008
Recall Status1 Terminated on November 12, 2009
Recall Number Z-1480-2008
Recall Event ID 47233
Premarket Notification
510(K) Number
K920227 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
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, Indiana 46580-2746
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
DESIGN: Packaging Design/Selection
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.
Quantity in Commerce 14,654 of H.A.S.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = MAGNETIC RESEARCH, INC.
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