Vascular Pack recall: Sterility Concern
Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
Why was Vascular 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 89251, 12/25/2018 89524, 10/25/2018 89601, 12/17/2018 89838, 12/17/2018 99349, 6/18/2019 99729, 10/7/2019
- Product
- Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 360 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)