The Recall Desk
HighFDA (Devices)·Z-1326-2017·Announced 2017-03-08

Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 225 Lap Gallbladder 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 involves a risk-of-harm product where sterility is compromised, which poses a risk of infection, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 225 units of the Lap Gallbladder Pack, part number AMS3707. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. These gloves may contain splits or holes that compromise the sterility of the medical device.

The affected 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. The recall covers specific lot numbers and expiration dates, including 100414 (10/20/2019), 84309 (5/14/2018), 84891 (6/9/2018), 85661 (7/14/2018), 86668 (9/5/2018), 87290 (8/9/2019), 88195 (11/15/2018), 94578 (12/14/2018), 95117 (3/6/2019), 97136 (5/29/2019), 98513 (6/2/2019), and 99066 (6/20/2019).

Healthcare facilities and consumers should stop using these kits immediately. Users should check their inventory for the part number AMS3707 and the listed lot numbers and expiration dates. If a kit matches the recalled description, it should be returned to Windstone Medical Packaging, Inc. for credit or replacement.

The recalled product

Product
Lap Gallbladder Pack, part number AMS3707
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
225

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 100414
  • 10/20/2019 84309
  • 5/14/2018 84891
  • 6/9/2018 85661
  • 7/14/2018 86668
  • 9/5/2018 87290
  • 8/9/2019 88195
  • 11/15/2018 94578
  • 12/14/2018 95117
  • 3/6/2019 97136
  • 5/29/2019 98513
  • 6/2/2019 99066
  • 6/20/2019

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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