The Recall Desk
HighFDA (Devices)·Z-0188-2017·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

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 surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.

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 the custom AMS kit (Kit number AMS3641) manufactured by Windstone Medical Packaging, Inc., which is used for general surgery in hospital operating rooms.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. A total of 27 kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lot numbers are 73462 (expiration date 4/16/2017) and 74265 (expiration date 5/25/2017).

Healthcare facilities should stop using the affected gloves and contact the recalling firm for further instructions. Consumers are not expected to have these products in their homes, as they are distributed to hospitals.

The recalled product

Product
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
27

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: 73462 4/16/2017 74265 5/25/2017

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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