Extended PTFE Coated Blade electrosurgical electrodes, 6.5" (16.51CM) Length, 12 each & 20 each per box, Labeled MEDLINE
FDA device recall Z-0069-2010 · posted 2009-10-21 · Terminated
Recall details
- Recalling firm
- Unimed Surgical Products, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1920 units
- Distribution
- Nationwide Distribution -- MI
- Date initiated
- 2009-08-28
- Date posted
- 2009-10-21
- Date terminated
- 2010-05-12
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (K962935) | Unimed Surgical Products, Inc. | 1996-09-03 |