The Recall Desk
HighFDA (Devices)·Z-1324-2017·Announced 2017-03-08

Medtronic Gloves in AMS Lap Band Kits Recalled for Sterility Risk

Windstone Medical Packaging is recalling 252 Lap Band kits 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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 252 Lap Band Packs (part number AMS1785(A)) because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise the sterility of the gloves.

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 ranging from February 2017 to March 2018.

Healthcare facilities and consumers should stop using the affected gloves and contact Windstone Medical Packaging for further instructions on returning or replacing the product.

The recalled product

Product
Lap Band Pack, part number AMS1785(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
252

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 85157
  • 2/28/2017 86861
  • 2/28/2017 87419
  • 4/30/2017 88367
  • 3/31/2017 89154
  • 7/31/2017 94568
  • 7/31/2017 94919
  • 11/30/2017 95972
  • 10/31/2017 96744
  • 11/30/2017 97772
  • 11/30/2017 98016
  • 11/30/2017 98495
  • 3/31/2018

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 →