Windstone Medical Packaging Recalls Student Pack-NS Surgical Kits
Windstone Medical Packaging is recalling Student Pack-NS surgical kits because the Medtronic gloves included 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 risk-of-harm product (sterile surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential compromise of sterility.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling five Student Pack-NS convenience custom kits (Kit number PSS2788) 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 have Lot Number 58594 and an expiration date of 7/23/2016. These products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Hospitals and healthcare facilities should stop using these kits and contact Windstone Medical Packaging for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 5
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: 58594 7/23/2016
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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