The Recall Desk
HighFDA (Devices)·Z-2292-2012·Announced 2012-09-05

Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.

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 risk-of-harm product (sterility concerns) where no specific injuries or illnesses have been reported in the source text.

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 PTFE Coated Blade, 6.5 inches (16.51 cm) in length. The specific lot number is 042209-03, and the part number is ES0014. A total of 1,920 units were distributed nationwide, including the state of Illinois.

The FDA has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***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
1,920

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 # 042209-03.

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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