Windstone Medical Recalls Hernia Packs with Defective Gloves
Windstone Medical Packaging is recalling 228 Hernia Packs because the included Medtronic gloves 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 is classified as FDA Class II. The hazard involves compromised sterility in a medical device, which poses a risk of harm (infection) but does not meet the criteria for Critical or Severe as no injuries or hospitalizations are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 228 kits of the Hernia Pack, part number AMS3859. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits.
The gloves may contain splits or holes that compromise sterility. The affected 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 should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or replacement. Specific lot numbers and expiration dates for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Hernia Pack, part number AMS3859
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 228
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 (11)
- Lot number and expiration date 101167
- 5/30/2019 87349
- 6/20/2018 88830
- 9/11/2018 89510
- 11/29/2018 94616
- 11/15/2018 94704
- 11/24/2018 95209
- 11/25/2018 95934
- 1/15/2019 97409
- 3/6/2019 99486
- 3/12/2019
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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