Agency classClass IIOur severity:High FDA (Devices)·Z-1269-2017·Announced 2017-03-08

Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 276 Basic Setup Packs because the Medtronic gloves inside may have 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) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 276 Basic Setup Packs, part numbers AMS1787(A and AMS6519. These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product.

The affected kits were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington. The recall covers specific lot numbers and expiration dates ranging from 2018 to 2020.

Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product: Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 276

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 (16)

Lot number and expiration date 101418
10/9/2019 84727
5/25/2018 85308
6/3/2018 85485
8/5/2018 86644
9/11/2018 87420
9/14/2018 88160
11/15/2018 89015
10/8/2018 89570
12/1/2018 94914
1/21/2019 94920
1/12/2019 95736
1/2/2019 96290
1/28/2019 96902
8/16/2020 99041
9/25/2019

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 124 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 124 products in this recall →

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise