Windstone Medical Packaging Recalls D & C Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 136 D & C Kits because the 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 medical device where a defect (splits/holes) compromises sterility, creating a risk of infection or harm. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 136 D & C Kits, part number CMP1466(A. The recall is due to a potential defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. These gloves may contain splits or holes that compromise sterility.
The affected kits 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. The recall covers specific lot numbers and expiration dates, including 85461 (8/5/2018), 86216 (8/24/2018), 87933 (11/15/2018), 96803 (3/8/2019), 97312 (5/5/2019), and 98203 (6/6/2019).
Healthcare facilities and consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, Windstone Medical Packaging, Inc.
The recalled product
- Product
- D & C Kit, part number CMP1466(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 136
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 (7)
- Lot number and expiration date 85461
- 8/5/2018 86216
- 8/24/2018 87933
- 11/15/2018 96803
- 3/8/2019 97312
- 5/5/2019 98203
- 6/6/2019
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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