The Recall Desk
HighFDA (Devices)·Z-1342-2017·Announced 2017-03-08

Windstone Medical Minor Procedure Packs Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 365 Minor Procedure Packs because the 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 (sterility compromise) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 365 units of the Minor Procedure Pack, part number AMS4799. These kits were distributed across 27 states, including Arizona, California, and Texas.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects can compromise the sterility of the medical devices.

Healthcare facilities and consumers should stop using these specific kits immediately. Affected lots include 100253, 88213, 88671, 88876, 89097, 89205, 94555, 94588, 95305, 96331, 97150, and 98711. Users should contact Windstone Medical Packaging for instructions on returning the product.

The recalled product

Product
Minor Procedure Pack, part number AMS4799
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
365

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 (13)

  • Lot number and expiration date 100253
  • 3/31/2018 88213
  • 4/30/2017 88671
  • 4/13/2017 88876
  • 4/22/2017 89097
  • 4/30/2017 89205
  • 4/15/2017 94555
  • 3/31/2017 94588
  • 3/31/2017 95305
  • 3/31/2017 96331
  • 10/26/2017 97150
  • 11/30/2017 98711
  • 11/30/2017

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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