PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulat
FDA device recall Z-1347-2013 · posted 2013-05-22 · Terminated
Recall details
- Recalling firm
- Unimed Surgical Products, Inc.
- Reason for recall
- Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 120,416 units
- Distribution
- Distributed in the states of MO, TN, and PA.
- Date initiated
- 2013-02-15
- Date posted
- 2013-05-22
- Date terminated
- 2013-08-07
- Location
- Largo, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE (K970066) | Unimed Surgical Products, Inc. | 1997-02-18 |
| UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (K962935) | Unimed Surgical Products, Inc. | 1996-09-03 |