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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Unimed Surgical Products, Inc.
- 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
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
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- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
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