Medline PTFE Coated Needle Recall Due to Sterility Concerns
Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are 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 is classified as FDA Class II. The hazard involves a risk of harm (sterility failure) for a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Unimed Surgical Products, Inc. initiated a recall of Medline Standard PTFE Coated Needles on June 16, 2010. The recall was triggered by concerns regarding the sterility of the devices. These electrosurgical electrodes are intended for the cutting and coagulation of soft tissue.
The recall affects 3,600 units of the product, specifically Part # ES0013. The affected lot numbers are 030309-02 and 030509-05. The products were distributed nationwide, including the state of Illinois.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with recall instructions.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***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
- 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 (1)
- Lot # 030309-02 and 030509-05
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
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- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
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- HighUnimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
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