The Recall Desk
HighFDA (Devices)·Z-0248-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic is recalling disposable gloves used in custom surgical kits because splits or holes may 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. The hazard involves a risk of harm (loss of sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are components of custom AMS kits. The recall was initiated because the gloves may contain splits or holes that compromise sterility.

These gloves are used in custom kits for general surgery in hospital operating rooms. The recall involves 16 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lots are 57967 (expiration 11/11/2015) and 67251 (expiration 7/10/2016).

Healthcare facilities should stop using the affected gloves and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
16

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 Numbers/ Expiration Dates: 57967 11/11/2015 67251 7/10/2016

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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