The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0267-2017·Announced 2016-10-26

Windstone Medical Packaging Recalls Surgical Set Up Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves 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 medical device where a defect (glove splits/holes) compromises sterility, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 16 units of the Set Up Pack, Kit number PSS3574(A). These are convenience custom kits used for general surgery in hospital operating rooms. The specific lot number is 80547, with an expiration date of 8/8/2017.

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 surgical kit.

The affected kits 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 these specific kits and contact the recalling firm for further instructions.

The recalled product

Product
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
16

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: 80547 8/8/2017

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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