The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0234-2017·Announced 2016-10-26

Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling Major Lithotomy 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting 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 156 Major Lithotomy Packs, kit numbers 002641-5 and 002641-6. 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. The gloves may contain splits or holes, which compromises the sterility of the product.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves specific lot numbers and expiration dates, including 60743 (1/13/2014), 66029 (1/31/2014), 66769 (1/31/2014), 64456 (9/28/2014), 65289 (9/30/2014), 68942 (9/9/2015), 70848 (9/11/2015), and 58030 (7/11/2016).

Hospitals and healthcare facilities should check their inventory for these specific kit numbers and lot dates. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA has classified this as a Class II recall.

The recalled product

Product
Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
156

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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