General Plastics Pack recall: Sterility Concern
General Plastics Pack, part number 008617-1
Why was General Plastics 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 85096, 12/11/2017 85458, 12/20/2017 88364, 12/27/2017 89172, 9/3/2018 95260, 9/20/2018 95790, 9/9/2018 96288, 9/18/2018 96562, 9/20/2018 97526, 9/27/2018 97560, 9/13/2018 99232, 2/1/2019 99232, 2/1/2019
- Product
- General Plastics Pack, part number 008617-1
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 465 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)