The Recall Desk
HighFDA (Devices)·Z-1336-2017·Announced 2017-03-08

Windstone Medical Recalls Lumbar Laminectomy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 123 Lumbar Laminectomy Packs because the included 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 medical device where a defect (glove splits/holes) compromises sterility, posing a risk of infection or harm during surgery. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 123 Lumbar Laminectomy Packs, part number AMS2501, AMS2501(A, and AMS2501(B. 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 surgical pack.

The affected products 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 with expiration dates ranging from January 2018 to January 2019.

Healthcare facilities and consumers should stop using the affected Lumbar Laminectomy Packs immediately. Users should contact Windstone Medical Packaging, Inc. for instructions on returning the product or obtaining a replacement.

The recalled product

Product
Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Packs
Hazard
Affected units
123

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 (9)

  • Lot number and expiration date 83672
  • 5/11/2018 84748
  • 6/3/2018 86722
  • 8/19/2018 88051
  • 1/7/2018 89026
  • 11/21/2018 89027
  • 12/12/2018 89882
  • 12/10/2018 94933
  • 1/29/2019

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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