The Recall Desk
HighFDA (Devices)·Z-0207-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

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 (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

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

These gloves are used in general surgery within hospital operating rooms. The recall involves 70 kits distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lots have expiration dates ranging from January 1, 2016, to November 4, 2017.

Healthcare facilities should stop using the affected gloves and contact the manufacturer for further instructions. Consumers are not directly affected as these products are distributed to hospitals.

The recalled product

Product
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
70

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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