Basic Kit recall: Sterility Concern
Basic Kit, part number CMP1109(A
Why was Basic Kit 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 84274, 5/14/2018 85771, 7/29/2018 86323, 9/5/2018 87540, 9/30/2018 88763, 12/2/2018 89683, 11/16/2018 95028, 1/5/2019 96659, 5/12/2019 97882, 6/4/2019 98262, 6/15/2019 99290, 9/27/2019
- Product
- Basic Kit, part number CMP1109(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 216 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)