The Recall Desk
HighFDA (Devices)·Z-0150-2017·Announced 2016-10-26

FDA Recalls Windstone Medical Basin Packs Due to Sterility Compromise

Windstone Medical Packaging is recalling 1,243 Basin Packs (kit AMS2497) because included Medtronic gloves may contain 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 (sterile surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Windstone Medical Packaging, Inc. Basin Packs, kit number AMS2497. These are convenience custom kits used for general surgery in hospital operating rooms. The recall involves 1,243 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit, may contain splits or holes. These defects can compromise the sterility of the gloves, posing a risk to patients during surgical procedures.

Healthcare facilities should stop using the affected kits immediately. The affected lots have expiration dates ranging from July 5, 2016, to January 17, 2018. Specific lot numbers include 67015, 67549, 68418, 68820, 68959, 69548, 69852, 70495, 71780, 71957, 71958, 72481, 73643, 73644, 73850, 74062, 76185, 76345, 76673, 77769, 78025, 78741, and 80940. Consumers and healthcare providers should contact Windstone Medical Packaging for further instructions on returning or disposing of the recalled products.

The recalled product

Product
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
1,243

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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Same hazard · sterility compromise

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