The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0233-2017·Announced 2016-10-26

Windstone Medical Packaging Recalls Major Laparotomy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 12 Major Laparotomy Packs because the included Medtronic gloves may contain 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility in surgical gloves, which poses a significant risk of infection or serious injury during surgery, meeting the criteria for a Severe rating.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 12 units of the Major Laparotomy Pack - NS, kit number AMS4347. These convenience custom kits are used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit.

The gloves may contain splits or holes that compromise sterility. The affected lot number is 78422 with an expiration date of 11/9/2015. The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Hospitals and healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as these products are intended for professional medical use.

The recalled product

Product
Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
12

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: 78422 11/9/2015

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 →

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