Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.
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 involves a risk-of-harm product (sterility concerns for 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 on June 16, 2010, for Medline Industries, Inc. electrosurgical electrodes. The specific product involved is the Medline Straight Microsurgical Needle, 3cm (1.81 inch) length, Part # ESE1651, Lot # 03059-03. These needles are intended for the cutting and coagulation of soft tissue.
The recall was initiated due to concerns regarding the sterility of the devices. The source text does not specify the exact nature of the sterility failure or report any illnesses or injuries associated with the use of these products.
The affected units were distributed nationwide, including the state of Illinois. Consumers and healthcare facilities should stop using the recalled needles and contact the recalling firm for further instructions.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81 ) Length***Reorder: ESE1651***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.
- 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 # 03059-03
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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