Windstone Medical Recalls Lipo Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 40 Lipo Pack kits 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 involves a medical device where a defect (glove splits/holes) compromises sterility, creating a risk of harm (infection) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 40 Lipo Pack kits (Kit number AMS4420) 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 kits. The gloves may contain splits or holes that compromise sterility.
The affected kits have lot number 79639 and an expiration date of 1/9/2018. The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions.
The recalled product
- Product
- Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 40
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: 79639 1/9/2018
Distribution
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.
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