Windstone Medical Spine Pack Gloves Recalled for Sterility Compromise
Windstone Medical Packaging recalled 286 Spine Pack kits 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 286 Spine Pack kits, including part numbers AMS3753(A, AMS3783(A, AMS3783(B, and AMS6472. The recall involves Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in custom Aligned Medical Solutions (AMS) kits.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lots have expiration dates ranging from February 2017 to November 2018.
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. Consumers and healthcare facilities should stop using the affected kits and contact the recalling firm for instructions.
The recalled product
- Product
- Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 286
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 (13)
- Lot number and expiration date 100932
- 1/28/2018 101802
- 11/13/2018 84360
- 6/3/2017 85663
- 7/20/2017 86544
- 7/4/2017 87130
- 8/24/2017 87382
- 10/31/2017 87650
- 9/9/2017 87669
- 8/6/2017 88935
- 11/11/2017 94580
- 2/18/2017 97848
- 12/11/2017
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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