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
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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
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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 |
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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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