The Recall Desk
HighFDA (Devices)·Z-0266-2017·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.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit. The recall is due to the possibility that the gloves may contain splits or holes that compromise sterility.

The affected product is the Robotic Pack, Kit number AMS4389, which consists of convenience custom kits used for general surgery in hospital operating rooms. A total of 33 kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lots are identified by the following lot numbers and expiration dates: 79062 (9/16/2017) and 79998 (1/27/2018).

Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging, Inc. for further instructions on how to return or dispose of the product.

The recalled product

Product
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
33

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 Number/ Expiration Date: 79062 9/16/2017 79998 1/27/2018

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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