The Recall Desk
HighFDA (Devices)·Z-0186-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because they may contain splits or holes that compromise 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 involves a risk-of-harm product (sterile gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.

Plain-English summary

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are part of the custom AMS kit. The recall was initiated because the gloves may contain splits or holes that could compromise sterility.

The affected gloves are part of the Eye Plastic Tray, Kit number PSS1931(A), which are convenience custom kits used for general surgery in hospital operating rooms. The recall involves 720 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the affected gloves are found, they should be removed from use and returned to the manufacturer or disposed of according to facility policy.

The recalled product

Product
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
720

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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