Major Kit recall: Sterility Concern
Major Kit, part number PHC1307(A
Why was Major 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 84334, 6/8/2018 86584, 8/7/2018 89801, 1/24/2019 96122, 3/6/2019 97375, 6/2/2019 98632, 6/3/2019
- Product
- Major Kit, part number PHC1307(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 85 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)