The Recall Desk
HighFDA (Devices)·Z-1370-2017·Announced 2017-03-08

Windstone Medical Spine Pack Gloves Recalled for Sterility Compromise

Windstone Medical Packaging recalled 286 Spine Pack kits because the disposable 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 (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 286 Spine Pack kits, including part numbers AMS3753(A, AMS3783(A, AMS3783(B, and AMS6472. The recall involves Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in custom Aligned Medical Solutions (AMS) kits.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lots have expiration dates ranging from February 2017 to November 2018.

The 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. Consumers and healthcare facilities should stop using the affected kits and contact the recalling firm for instructions.

The recalled product

Product
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
286

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 100932
  • 1/28/2018 101802
  • 11/13/2018 84360
  • 6/3/2017 85663
  • 7/20/2017 86544
  • 7/4/2017 87130
  • 8/24/2017 87382
  • 10/31/2017 87650
  • 9/9/2017 87669
  • 8/6/2017 88935
  • 11/11/2017 94580
  • 2/18/2017 97848
  • 12/11/2017

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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