The Recall Desk
HighFDA (Devices)·Z-0204-2017·Announced 2016-10-26

Medtronic Disposable Surgical 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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) in a medical device 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 custom AMS kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise their sterility.

The affected product is a convenience custom kit used for general surgery in hospital operating rooms. The recall involves 8,132 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The kits are identified by specific lot codes and expiration dates ranging from March 2014 to October 2017.

Hospitals and healthcare facilities should check their inventory for the affected lot codes and expiration dates. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.

The recalled product

Product
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
8,132

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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