The Recall Desk
HighFDA (Devices)·Z-0280-2017·Announced 2016-10-26

Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that 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 and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 108 Upper Extremity Packs, identified by kit numbers AMS2536 and AMS2536(A). These convenience custom kits are used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the kits, which may contain splits or holes that compromise sterility.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates for the recalled units are 62892 (3/18/2014), 61288 (3/30/2014), 66302 (11/8/2015), 64646 (11/30/2015), 68734 (12/19/2015), and 68513 (12/31/2015).

Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
108

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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