The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0153-2017·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.

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. The hazard involves compromised sterility in surgical gloves, which is a risk-of-harm product 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 (Bleph Pack, Kit part number AMS3325), which is used for general surgery in hospital operating rooms. The recall was initiated by Windstone Medical Packaging, Inc.

The recall is necessary because the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection or other adverse health consequences to patients during surgical procedures. The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot number is 71657 with an expiration date of 3/14/2016.

Healthcare facilities and consumers who have these specific gloves should stop using them immediately and contact the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
10

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 Number/Expiration Date: 71657 3/14/2016

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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Same manufacturer · Windstone Medical Packaging, Inc.

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