The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1286-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 544 Custom Venous Kits, part number TVS4024(C. The recall involves Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in these custom Aligned Medical Solutions (AMS) kits.

The gloves are being recalled because they may contain splits or holes that compromise sterility. The affected lots have expiration dates ranging from January 1, 2018, to January 24, 2018. The 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.

Healthcare facilities and consumers should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for further instructions.

The recalled product

Product
Custom Venous Kit, part number TVS4024(C
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Supplies
Hazard
Affected units
544

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 (10)

  • Lot number and expiration date 84766
  • 1/8/2018 85230
  • 1/12/2018 85938
  • 1/7/2018 88327
  • 1/6/2018 88591
  • 1/9/2018 96129
  • 1/11/2018 96256
  • 1/1/2018 96660
  • 1/2/2018 98425
  • 1/24/2018

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 →

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