Hand Pack recall: Sterility Concern
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part…
Why was Hand 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 100610, 8/6/2018 84646, 5/12/2017 84692, 7/28/2017 84730, 5/18/2017 84851, 6/1/2017 84859, 2/28/2017 85509, 7/1/2017 86309, 8/26/2018 86748, 8/17/2018 86839, 8/2/2018 86937, 10/14/2017 87631, 10/5/2017 87866, 9/15/2018 88208, 4/6/2017 88209, 7/31/2017 88266, 10/29/2018 88267, 1/5/2020 88279, 1/3/2019 88402, 11/2/2017 88875, 10/31/2017 89734, 12/16/2017 94987, 3/21/2018 95112, 2/2/2018 96198, 2/10/2018 96608, 1/7/2018 97288, 2/7/2018 97796, 5/6/2018 98564, 3/19/2018 99383, 5/11/2018
- Product
- Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 102 6 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)