The Recall Desk
HighFDA (Devices)·Z-0199-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES 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 (sterile surgical gloves) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

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

The affected gloves are part of the GLBSC Minor Pack, Kit number PSS2644, which are convenience custom kits used for general surgery in hospital operating rooms. The recall involves 60 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

The affected lots have the following numbers and expiration dates: 58663 (4/6/2015), 62629 (11/19/2015), and 61998 (11/27/2015). The recalling firm is Windstone Medical Packaging, Inc. Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
60

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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