Custom Venous Kit recall: Sterility Concern
Custom Venous Kit, part number TVS4024(C
Why was Custom Venous 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 84766, 1/8/2018 85230, 1/12/2018 85938, 1/7/2018 88327, 1/6/2018 88591, 1/9/2018 96129, 1/11/2018 96256, 1/1/2018 96660, 1/2/2018 98425, 1/24/2018
- Product
- Custom Venous Kit, part number TVS4024(C
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 544 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)