Windstone Medical Vein Kit Recall Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 Vein Kits because disposable gloves in the kits 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 the defect (compromised sterility) poses a risk of infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 360 units of the Vein Kit - No Introducer (TVS4027-NI(A). These convenience custom kits are 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 kits were distributed nationwide to 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 2015 to November 2017.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions. Consumers are not expected to have these products in their homes, as they are intended for hospital use.
The recalled product
- Product
- Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 360
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.
See all 150 products in this recall →Related recalls
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