Agency classClass IIOur severity:High FDA (Devices)·Z-0218-2017·Announced 2016-10-26

Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise

Windstone Medical Packaging is recalling 258 Lap/Pelviscopy 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 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 kit) where sterility is compromised, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 258 units of the Lap/Pelviscopy Pack, identified by kit numbers AMS4151, PSS3256, and PSS3256(A. These are convenience custom kits 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) included in the custom AMS kit, which may contain splits or holes that compromise sterility.

The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates for the recalled kits are 68014 (8/28/2016), 70788 (1/4/2017), 72355 (1/21/2017), 72522 (1/23/2017), 76700 (7/16/2017), and 69491 (12/17/2017).

Hospitals and healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on how to return or dispose of the affected products. Consumers should not use these medical kits at home, as they are intended for professional surgical use.

The recalled product

Product: Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 258

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 →

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise