Recall Z-1142-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConvaTec
Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
| Date | Mar 16, 2010 (initiated Jan 22, 2010) |
| Status | Terminated |
| Reason | Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M. |
| Root cause | Other |
| Action | Unomedical Urgent Medical Device Correction letters were sent to distributors on January 22, 2010 by certified mail. Letters state that the only way to determine if the incorrect product is contained in the carton is to open the box. Distributors are asked to inspect all Diathermy Cables in their possession with order code 3508M or 3405M to ensure that the correct cable is inside. The number of mislabeled product is to be recorded on the Questionnaire for Distributors, and then mislabeled product is to be destroyed by cutting the product in half. The questionnaires include an area for name |
| Quantity | 5130 cables worldwide, 1270 in US. |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982130 | RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 New Deantronics, Ltd., Aug 7, 1998 |