The Recall Desk
HighFDA (Devices)·Z-1282-2017·Announced 2017-03-08

Windstone Medical C-Tray Packs Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling 66 C-Tray 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 66 C-Tray Packs, part number PSS2707(A. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. The gloves may contain splits or holes that compromise sterility.

The affected lots are 84507 (exp. 9/18/2017), 98125 (exp. 1/1/2018), 98289 (exp. 6/12/2019), 98579 (exp. 1/29/2018), and 98645 (exp. 1/26/2019). These 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.

Healthcare facilities and consumers should stop using these kits immediately and contact Windstone Medical Packaging for instructions on return or replacement.

The recalled product

Product
C-Tray Pack, part number PSS2707(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
66

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 (6)

  • Lot number and expiration date 84507
  • 9/18/2017 98125
  • 1/1/2018 98289
  • 6/12/2019 98579
  • 1/29/2018 98645
  • 1/26/2019

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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