Recall Z-1595-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Centurion Medical Products
Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
| Date | May 12, 2010 (initiated Apr 9, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 74 kits |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.