Recall Z-1347-2013 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Unimed Surgical Products, Inc.
PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
| Date | May 22, 2013 (initiated Feb 15, 2013) |
| Status | Terminated |
| Reason | Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials. |
| Root cause | No Marketing Application |
| Action | Unimed Surgical Products, Inc. issued a Medical Device Correction and Removal letter dated February 15, 2013 to its customers. Customers were instructed to quarantine any undistributed product, and notify its customers of the recall to retrieve any unused product. For further information, contact Unimed Surgical Products Inc. at 1-800-531-2627. |
| Quantity | 120,416 units |
| Distribution | Distributed in the states of MO, TN, and PA. |
| FDA record | Open on fda.gov |