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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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  Class 2 Device Recall Centurion see related information
Date Initiated by Firm April 09, 2010
Date Posted May 12, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-1595-2010
Recall Event ID 55305
Product Classification general surgery kit - 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 MI 48843-1703
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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 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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