Newport Coast Basic Pack recall: Sterility Concern
Newport Coast Basic Pack, part number 007484-1
Why was Newport Coast Basic 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 101006, 9/30/2019 88154, 11/11/2018 88970, 1/5/2019 96163, 1/23/2019 96254, 5/23/2019 97206, 6/29/2019 99295, 6/24/2019
- Product
- Newport Coast Basic Pack, part number 007484-1
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 152 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)