Basin Pack recall: Sterility Concern
Basin Pack, part number AMS2497
Why was Basin Pack recalled?
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number and expiration date 84187, 5/14/2018 84938, 6/30/2018 85835, 9/12/2018 86871, 8/14/2019 87444, 9/30/2018 88377, 11/15/2018 88626, 10/8/2018 89025, 12/10/2018 89575, 1/30/2019 94929, 3/6/2019 96912, 5/5/2019 97575, 6/22/2019 97652, 9/27/2019
- Product
- Basin Pack, part number AMS2497
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 648 kits
- Distribution
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Recall date
- March 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)