Catheter Pack recall: Sterility Concern
Catheter Pack, part number AMS4399(A
Why was Catheter 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 84598 4/16/2017 84599 5/8/2018 85277 5/11/2018 85342 5/17/2018 85456 6/3/2018 85629 6/11/2018 85630 8/21/2018 87145 10/15/2018 89443 8/23/2018 89892 11/30/2018 95180 8/24/2018 95298 11/21/2018 95789 11/11/2018 96424 12/26/2018 96494 12/17/2018 96945 3/11/2019 97753 4/3/2019 97817 4/12/2019 98124 4/18/2019 98703 5/23/2019 98704 6/7/2019 98940 6/30/2019 99561 6/17/2019 99900 6/29/2019
- Product
- Catheter Pack, part number AMS4399(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 1116 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)