The Recall Desk
HighFDA (Devices)·Z-2294-2012·Announced 2012-09-05

Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a sterility concern for a sterile medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).

Plain-English summary

Unimed Surgical Products, Inc. initiated a recall on June 16, 2010, for Medline Industries, Inc. electrosurgical electrodes. These devices are intended for the cutting and coagulation of soft tissue. The recall was initiated due to concerns regarding the sterility of the products.

The affected product is the Medline Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length, Reorder code ES0009. The specific lot number involved is 052709-01. The recall covers 1,200 units that were distributed nationwide in the United States, including the state of Illinois.

Healthcare facilities and consumers should stop using the affected electrosurgical electrodes immediately. Users should contact Unimed Surgical Products, Inc. or Medline Industries, Inc. for further instructions on how to return or dispose of the recalled items.

The recalled product

Product
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
Manufacturer
Unimed Surgical Products, Inc.
Category
Medical Device — Electrosurgical Instruments
Hazard
Affected units
1,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 052709-01

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Unimed Surgical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

Related recalls

Same manufacturer · Unimed Surgical Products, Inc.

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Same hazard · sterility concern

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