The Recall Desk
SevereFDA (Devices)·Z-0274-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility in surgical gloves, which is a significant risk of harm (infection) in a medical setting, fitting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves were part of a custom AMS kit, specifically the Taymour GYN Pack (Kit number PSS2642), manufactured by Windstone Medical Packaging, Inc. The kits are convenience custom packs used for general surgery in hospital operating rooms.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection or other adverse health consequences for patients during surgical procedures.

The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates involved are 58661 (4/12/2015) and 61997 (11/30/2015). A total of 15 kits are affected. Healthcare facilities should stop using these specific kits and contact the recalling firm for further instructions.

The recalled product

Product
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
15

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 Number/ Expiration Date: 58661 4/12/2015 61997 11/30/2015

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 recalled by Windstone Medical Packaging, 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 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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