The Recall Desk
HighFDA (Devices)·Z-0239-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

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 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

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the Minor Lap Pack (Kit number AMS2624). These are convenience custom kits 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 130 kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lot numbers and expiration dates are 65441 (11/2/2015), 61136 (11/8/2015), 63732 (1/6/2016), 67075 (7/4/2016), and 67779 (9/25/2016).

Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as these products are distributed to hospitals.

The recalled product

Product
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
130

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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