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Terminated

PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.

FDA Recall Z-1347-2013 · Posted 2013-05-22

Recalling FirmUnimed Surgical Products, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2013-02-15
Date Terminated2013-08-07
Product Quantity120,416 units

Reason for Recall

Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

Distributed in the states of MO, TN, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970066UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODEUnimed Surgical Products, Inc. · 1997-02-18K962935UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODEUnimed Surgical Products, Inc. · 1996-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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