D&C/Cysto Pack recall: Sterility Concern
D&C/Cysto Pack, part number PSS3257(D
Why was D&C/Cysto 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 100086, 5/12/2019 85563, 8/13/2017 87345, 8/18/2017 89066, 8/8/2017 94998, 8/18/2017 95508, 8/12/2017 95667, 3/10/2017 96490, 8/5/2017 97900, 4/13/2019 99440, 4/5/2019
- Product
- D&C/Cysto Pack, part number PSS3257(D
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 380 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)