The Recall Desk
HighFDA (Devices)·Z-0245-2017·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 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

The U.S. Food and Drug Administration is recalling Medtronic 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 products are part of the Mok Eye Pack, Kit number PSS2640, which are convenience custom kits used for general surgery in hospital operating rooms. The recall involves 28 kits with lot numbers 58659 (expiration date 3/6/2014) and 59684 (expiration date 6/13/2014). These kits were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Windstone Medical Packaging, Inc. is the recalling firm. Hospitals and healthcare facilities should stop using the affected gloves and contact the manufacturer or the FDA for further instructions on how to handle the recalled items.

The recalled product

Product
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
28

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 Numbers/ Expiration Dates: 58659 3/6/2014 59684 6/13/2014

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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