The Recall Desk
HighFDA (Devices)·Z-0251-2017·Announced 2016-10-26

Medtronic Disposable 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 (compromised sterility) 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 recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the custom AMS kit (Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A), manufactured by Windstone Medical Packaging, Inc.). 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 120 kits with the following lot numbers and expiration dates: 76053 (11/18/2016), 75386 (1/18/2017), 79443 (8/17/2017), and 77581 (9/28/2017).

Hospitals and healthcare facilities should stop using these gloves and contact the recalling firm for instructions on return or disposal. Consumers should not use these products if they have them in their possession.

The recalled product

Product
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(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
120

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.

See all →

Same hazard · sterility compromise

See all →