Recall Z-0069-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Unimed Surgical Products, Inc.
Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE brand. Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA Made in USA MEDLINE in a registered trademark of Medline Industries, Inc. 1-800-MEDLINE.
| Date | Oct 21, 2009 (initiated Aug 28, 2009) |
| Status | Terminated |
| Reason | Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03. |
| Root cause | Process control |
| Action | Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall. For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225. |
| Quantity | 1920 units |
| Distribution | Nationwide Distribution -- MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE Unimed Surgical Products, Inc., Sep 3, 1996 |