Windstone Medical Robotic Pack Gloves Recalled for Sterility Compromise
Windstone Medical Packaging is recalling Robotic Packs because the disposable gloves 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 (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 57 kits of the Robotic Pack, part number AMS4389. The recall involves the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES contained within the custom Aligned Medical Solutions (AMS) kits.
The product is being recalled because the gloves may contain splits or holes that compromise sterility. The affected lots are 101356, 83800, 89442, 94546, and 95128, with expiration dates ranging from March 13, 2018, to September 9, 2019.
The products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- Robotic Pack, part number AMS4389
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 57
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 (6)
- Lot number and expiration date 101356
- 9/9/2019 83800
- 3/13/2018 89442
- 10/3/2018 94546
- 11/21/2018 95128
- 6/30/2019
Distribution
Part of a larger recall action
This product is one of 124 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 124 products in this recall →Related recalls
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