Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.
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 medical device used in surgical procedures, which poses a risk of harm even without reported injuries.
Plain-English summary
Unimed Surgical Products, Inc. initiated a recall on June 16, 2010, for Medline Industries, Inc. electrosurgical electrodes. The affected products are labeled as "Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length, Reorder: ES0016AM. The recall covers 1,440 units distributed nationwide, including Illinois.
The recall was initiated due to concerns regarding the sterility of the devices. The specific lots affected are 062408-08 and 062509-01. These electrosurgical electrodes are intended for the cutting and coagulation of soft tissue.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers should contact their healthcare provider if they have questions regarding the use of these devices.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE…
- Manufacturer
- Unimed Surgical Products, Inc.
- Affected units
- 1,440
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 #: 062408-08
- 062509-01.
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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