Recall Z-1347-2013— Unimed Surgical Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Unimed Surgical Products, Inc., initiated 2013-02-15, terminated 2013-08-07. It names 2 FDA 510(k) clearances: K970066, K962935. Product: PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.. Reason: Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials..
- Recalling firm
- Unimed Surgical Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-15
- Terminated
- 2013-08-07
- Firm location
- Largo, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K970066 — UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
- K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
Reason for recall
Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
Data sourced from openFDA. This site is unofficial and independent of the FDA.