The Recall Desk
SevereFDA (Devices)·Z-0141-2017·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

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves compromised sterility in surgical gloves, which carries a significant risk of infection or serious injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the Anterior Cervical Fusion Pack, a custom kit used for general surgery in hospital operating rooms. The recall is being conducted by Windstone Medical Packaging, Inc.

The recall was initiated because the gloves may contain splits or holes that could compromise sterility. This defect poses a risk of infection or other adverse health consequences if the non-sterile gloves are used during surgical procedures.

A total of 93 kits were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Affected lots include 62090, 64503, 65165, 66042, 68496, 75702, 76407, 78060, 78683, and 79143, with expiration dates ranging from November 2015 to November 2017. Healthcare facilities should stop using these specific gloves and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
93

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

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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