Windstone Medical Packaging Recalls Shoulder Arthroscopy Packs Due to Sterility Risk
Windstone Medical Packaging is recalling 606 Shoulder Arthroscopy Packs because the included Medtronic 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as compromised sterility leading to infection) map to a severity score of 4 (Severe), particularly given the lack of reported injuries which prevents a higher score but the structural defect prevents a lower score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 606 units of Shoulder Arthroscopy Packs. The affected products include part numbers AMS2496(A, AMS2496(B, AMS2496(C, AMS2609, AMS3857, AMS4766, AMS4766(A, and AMS4766(B. 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, which compromises the sterility of the medical device. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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. Consumers and healthcare providers should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or replacement.
The recalled product
- Product
- Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 606
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 (20)
- Lot number and expiration date 100823
- 10/13/2019 100856
- 9/5/2019 84375
- 5/20/2018 84747
- 7/23/2018 85059
- 7/21/2018 85549
- 7/13/2018 85838
- 8/1/2018 86718
- 9/5/2018 87103
- 9/12/2018 87106
- 9/15/2018 87277
- 8/10/2019 87347
- 6/22/2018 87916
- 6/22/2019 87962
- 11/15/2018 88047
- 9/4/2018 88376
- 12/29/2018 89418
- 11/12/2018 94736
- 1/21/2019 95273
- 6/12/2019 96914
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.
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