Transvaginal Pack recall: Sterility Concern
Transvaginal Pack, part number CMP1767
Why was Transvaginal 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 85689, 7/24/2018 85859, 8/1/2018 86125, 11/14/2018 89073, 11/25/2018 89074, 11/22/2018 89211, 12/11/2018 89212, 12/3/2018 89273, 6/15/2019 97315, 5/6/2019 97489, 6/27/2019 98343, 6/10/2019 98344, 9/9/2019
- Product
- Transvaginal Pack, part number CMP1767
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 650 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)