Laparotomy Pack recall: Sterility Concern
Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
Why was Laparotomy 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 100128, 9/28/2019 84856, 1/31/2019 86767, 12/22/2018 87491, 10/22/2017 88562, 10/20/2017 89958, 12/15/2018 94988, 12/5/2017 95849, 12/3/2017 96246, 3/3/2019 97441, 6/4/2019 97888, 6/16/2018 98626, 6/24/2019 98972, 7/22/2018 99473, 6/6/2019
- Product
- Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 331 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)