The Recall Desk
HighFDA (Devices)·Z-2293-2012·Announced 2012-09-05

Medline Electrosurgical Electrodes Recalled for Sterility Concerns

Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

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 due to sterility concerns in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Unimed Surgical Products, Inc. initiated a recall on June 16, 2010, for Medline Industries, Inc. electrosurgical electrodes. The specific product is the Extended PTFE Coated Blade with Extended Insulation, 4.0 (10.16cm) Length, with reorder number ES0014AM. The recall was initiated due to concerns regarding the sterility of the devices.

The affected units are labeled as single-use only, latex-free, and sterile EO (ethylene oxide). They are intended for the cutting and coagulation of soft tissue. The recall covers 2,400 units from lot numbers 050409-05 and 050609-05. These products were distributed nationwide in the United States, including the state of Illinois.

Consumers and healthcare facilities should stop using the affected electrosurgical electrodes and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
Manufacturer
Unimed Surgical Products, Inc.
Category
Medical Device — Electrosurgical Instruments
Hazard
Affected units
2,400

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 (2)

  • Lot # 050409-05
  • 050609-05.

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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