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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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 Class 2 Recall
Centurion
see related information
Date Posted May 12, 2010
Recall Status1 Terminated on October 25, 2010
Recall Number Z-1595-2010
Recall Event ID 55305
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
Code Information 2009100590, 2009110990, 2009121490, 2010011190 and 2010031590.
Recalling Firm/
Manufacturer
Centurion Medical Products
301 Catrell Dr
Howell, Michigan 48843-1703
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Matthew Price
517-546-3356
Manufacturer Reason
for Recall
The firm is conducting a sub recall of kits containing ConMed Goldline Rocker Switch Pencils. The pencils activation switch may remain in the "on" position after the switch has been depressed with excessive force, thereby continuously activating the pencil.
Action Centurion sent out an "Urgent Product Recall Notice" to one customer on 4/9/2010. The customer was instructed to discontinue use of the product. The customer was also instructed to return any instock product .
Quantity in Commerce 74 kits
Distribution TX
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
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