Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.
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. The hazard involves a risk-of-harm product (sterility failure in a surgical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Unimed Surgical Products, Inc. initiated a recall of Medline Industries, Inc. electrosurgical electrodes on June 16, 2010. The recall was initiated due to concerns regarding the sterility of the devices. These electrodes are intended for the cutting and coagulation of soft tissue.
The specific product involved is the Extended PTFE Coated Blade with Extended Insulation, 6.5 (16.51cm) Length, Reorder Number ES0014M. The recall covers 3,600 units from Lot # 050609-05, 052909-05, and 062309-04. The products were distributed nationwide in the United States, including the state of Illinois.
Healthcare providers and facilities should stop using the affected electrosurgical electrodes and contact Unimed Surgical Products for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
- Manufacturer
- Unimed Surgical Products, Inc.
- Affected units
- 3,600
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 (3)
- Lot # 050609-05
- 052909-05
- 062309-04.
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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FDA (Devices) · 2013-05-29
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
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- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
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