The Recall Desk
HighFDA (Devices)·Z-1332-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 331 laparotomy packs because the disposable gloves inside 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 (compromised sterility) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 331 units of Laparotomy Packs, including part numbers 006268-9, AMS4418(A, and PSS2190(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. These gloves may contain splits or holes that compromise the sterility of the medical device.

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. Specific lot numbers and expiration dates are listed in the agency's recall record.

Healthcare facilities and consumers should stop using these specific laparotomy packs and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
331

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 (15)

  • Lot number and expiration date 100128
  • 9/28/2019 84856
  • 1/31/2019 86767
  • 12/22/2018 87491
  • 10/22/2017 88562
  • 10/20/2017 89958
  • 12/15/2018 94988
  • 12/5/2017 95849
  • 12/3/2017 96246
  • 3/3/2019 97441
  • 6/4/2019 97888
  • 6/16/2018 98626
  • 6/24/2019 98972
  • 7/22/2018 99473
  • 6/6/2019

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.

See all →

Same hazard · sterility compromise

See all →