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.
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 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 products are labeled as "Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length" with reorder number ES0013M. The recall covers 1,800 units distributed nationwide in the United States, including the state of Illinois. The specific lot numbers involved are 030509-07 and 062309-02.
Healthcare providers and consumers should stop using these specific products immediately. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***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.
- Hazard
- Affected units
- 1,800
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 # 030509-07
- 062309-02.
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
Same manufacturer · Unimed Surgical Products, Inc.
See all →- ModerateUnimed Recalls Laparoscopic Electrode Hooks Due to Coating Material Changes
FDA (Devices) · 2013-05-29
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighUnimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighMedline PTFE Coated Needle Recall Due to Sterility Concerns
FDA (Devices) · 2012-09-05
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