Medtronic Disposable Gloves in Laminectomy Kits Recalled for Sterility Risk
Windstone Medical Packaging is recalling 838 laminectomy kits because the Medtronic disposable gloves included 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 gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 838 Laminectomy Packs (Kit numbers AMS2763, AMS2763(A, PSS1844, and PSS1844(B). These are convenience custom kits used for general surgery in hospital operating rooms. The recall is limited to specific lot numbers and expiration dates ranging from May 27, 2016, to October 10, 2016.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom AMS kits may contain splits or holes. These defects can compromise the sterility of the gloves, posing a risk to patients during surgical procedures.
The affected kits were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on returning the product.
The recalled product
- Product
- Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 838
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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