Basic Extended Pack recall: Sterility Concern
Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
Why was Basic Extended 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 84855, 8/6/2018 88319, 9/5/2018 88950, 11/15/2018 95760, 1/26/2019 96235, 5/14/2019 98080, 6/19/2019
- Product
- Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 170
- 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)