The Recall Desk
HighFDA (Devices)·Z-0158-2017·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 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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the custom AMS kit, specifically the C-Birth Pack (part numbers AMS2037 and AMS2037A), which 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. The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves 48 kits with specific lot numbers and expiration dates ranging from August 2013 to August 2016.

Healthcare facilities and consumers should stop using these gloves immediately. The recalling firm, Windstone Medical Packaging, Inc., is responsible for managing the recall. Users should contact the manufacturer or their supplier for instructions on returning or replacing the affected products.

The recalled product

Product
C-Birth Pack, Kit part number AMS2037 and AMS2037(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
48

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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