Agency classClass IIOur severity:High FDA (Devices)·Z-2286-2012·Announced 2012-09-05

Medline Extended PTFE Needle Recall for Sterility Concerns

Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units 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 and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Unimed Surgical Products, Inc. initiated a recall on June 16, 2010, for Medline Extended PTFE Needles. These electrosurgical electrodes are intended for the cutting and coagulation of soft tissue. The recall was initiated due to concerns regarding the sterility of the devices.

The affected products are labeled with the reorder code ES0016 and are identified by Lot # 030608-01 and 121808-19. A total of 1,440 units were distributed nationwide, including the state of Illinois. The devices are manufactured for Medline Industries, Inc. and are marked as single-use, latex-free, and sterile.

Healthcare providers and facilities should stop using the affected lots immediately. Consumers and medical staff should check their inventory for the specific lot numbers listed above. If you have used these devices, you should contact your healthcare provider for guidance.

The recalled product

Product: Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***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.
Category: Medical Device — Electrosurgical Instruments
Hazard: sterility-failure
infection-risk
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 #s: 030608-01
121808-19.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Unimed Surgical Products, Inc.

See all →

Moderate
Unimed Recalls Laparoscopic Electrode Hooks Due to Coating Material Changes
FDA (Devices) · 2013-05-29
High
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
High
Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
FDA (Devices) · 2012-09-05
High
Medline PTFE Coated Needle Recall Due to Sterility Concerns
FDA (Devices) · 2012-09-05
High
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05

Same hazard · sterility failure