Agency classClass IIOur severity:High FDA (Devices)·Z-1350-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Open Procedure Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 1,125 Open Procedure Packs because the disposable gloves included 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 involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,125 Open Procedure Packs, part number AMS4596, AMS4596(A, and AMS4596(B. These kits are custom Aligned Medical Solutions (AMS) kits that include Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES.

The recall was initiated because the gloves included in the kits may contain splits or holes, which could compromise the sterility of the medical devices. The affected lots have expiration dates ranging from October 2017 to June 2018. The products 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.

Healthcare facilities and consumers should stop using these specific kits and contact Windstone Medical Packaging for further instructions or a return.

The recalled product

Product: Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 1,125

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 (19)

Lot number and expiration date 100206
6/1/2018 100248
7/9/2018 100438
7/19/2018 100439
8/29/2018 100853
9/15/2018 86832
10/10/2017 88268
10/4/2017 89377
11/9/2017 89378
12/9/2017 94967
12/31/2017 95888
1/5/2018 96199
2/11/2018 97018
1/9/2018 97019
2/17/2018 97146
4/28/2018 97301
3/22/2018 97478
6/13/2018 98189
5/20/2018

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 →

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Same hazard · sterility compromise