The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0231-2017·Announced 2016-10-26

Windstone Medical Recalls Major General Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside 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 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 and involves a sterility compromise in surgical gloves, which poses a significant risk of infection during surgery, meeting the criteria for a Severe rating.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 852 units of the Major General Pack, kit numbers 002645-11 and 002645-12. 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, which are included in the custom AMS kit.

The FDA identified that the gloves may contain splits or holes, which could compromise the sterility of the surgical kit. This defect poses a risk of infection or other complications during surgery if the compromised gloves are used. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The affected kits were distributed nationwide to hospitals in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers with expiration dates ranging from August 20, 2013, to August 10, 2016. Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on return or disposal.

The recalled product

Product
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
852

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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