Hand Tray recall: Sterility Concern
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
Why was Hand Tray 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 84418, 1/30/2017 85478, 5/15/2017 85479, 5/21/2017 86212, 1/27/2017 86213, 1/27/2017 86630, 1/14/2017 87353, 1/24/2017 87946, 1/30/2017 88345, 2/22/2017 89564, 2/19/2017 94774, 1/17/2017 95066, 1/30/2017 95322, 1/25/2017 95854, 2/18/2017 96363, 2/10/2017 96634, 2/7/2018 97251, 2/7/2018 97325, 2/18/2018 98448, 2/10/2018 98449, 5/12/2018 98450, 10/24/2018 98451, 10/24/2018 98452, 10/31/2018 98453, 10/30/2018 98576, 10/20/2018 98577, 4/16/2019
- Product
- Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1416 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)