The Recall Desk
HighFDA (Devices)·Z-0190-2017·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.

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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) in a medical device 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 included in custom AMS kits. The recall was initiated because the gloves may contain splits or holes that could compromise sterility.

The affected gloves are part of the Facial Tray, Kit number PSS1558(A, which are convenience custom kits used for general surgery in hospital operating rooms. Windstone Medical Packaging, Inc. is the recalling firm for these kits. The distribution was nationwide, specifically to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

A total of 282 kits are involved in this recall. The affected lots have expiration dates ranging from November 3, 2015, to February 23, 2018. Specific lot numbers include 59208, 66913, 64949, 63581, 56990, 58800, 68611, 69745, 73553, 70679, 73768, 74539, 75798, 79480, and 80615. Healthcare facilities should check their inventory for these specific lot numbers and expiration dates.

The recalled product

Product
Facial Tray, Kit number PSS1558(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
282

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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