The Recall Desk
HighFDA (Devices)·Z-1291-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits because splits or holes may 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 (infection due to compromised sterility) without reported illnesses, which aligns with 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 the Dr. Casey Pack, part number AMS4313(A, which contains Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. The recall involves 66 kits distributed across 27 states, including Arizona, California, and Texas. The specific lot numbers and expiration dates affected are 89198 (4/22/2018), 94965 (3/31/2018), 95296 (2/20/2018), and 96567 (4/18/2018).

The recall was initiated because the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection if the non-sterile gloves are used in sterile medical procedures. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

Healthcare facilities and consumers who have these specific kits should stop using the gloves immediately. Users should check their inventory for the part number AMS4313(A and the listed lot numbers and expiration dates. If the product matches the description, it should be quarantined and returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Dr. Casey Pack, part number AMS4313(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
66

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 (5)

  • Lot number and expiration date 89198
  • 4/22/2018 94965
  • 3/31/2018 95296
  • 2/20/2018 96567
  • 4/18/2018

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.

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Same hazard · sterility compromise

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