The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0176-2017·Announced 2016-10-26

Windstone Medical Recalls Dr. Fetters Hand Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that 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 surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential compromise of sterility without confirmed illness.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 40 units of the Dr. Fetters Hand Pack, Kit number AMS3690. These are convenience custom kits used for general surgery in hospital operating rooms. The recall is limited to Lot Number 75188 with an expiration date of 12/2/2015.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit may contain splits or holes. These defects could compromise the sterility of the gloves, posing a risk to patient safety during surgical procedures.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Hospitals and medical facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions.

The recalled product

Product
Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
40

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 (1)

  • Lot Number/Expiration Date: 75188 12/2/2015

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 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 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

Same hazard · sterility compromise

See all →

Similar recalls