The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0189-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits

The FDA is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone Medical Packaging facial plastic kits because the gloves may contain splits or holes that compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a risk of harm (compromised sterility) in a medical device, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are components of custom AMS kits. These gloves were included in Facial Plastic Packs (Kit numbers AMS2533, AMS2533(A, and AMS3327) manufactured by Windstone Medical Packaging, Inc. The recall is due to the possibility that the gloves contain splits or holes, which compromises their sterility.

The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. A total of 111 kits are involved in this recall. The specific lot numbers and expiration dates for the affected kits are 61285 (3/28/2014), 66414 (11/5/2015), 64644 (11/9/2015), 67019 (12/10/2015), 68565 (12/20/2015), 71659 (4/20/2016), 69369 (5/8/2016), and 72748 (8/23/2016).

Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact Windstone Medical Packaging, Inc. for instructions on return or disposal. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
111

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 →

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