Boston Scientific Wallstent Enteral Endoprosthesis recall: Labeling Error
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Why was Boston Scientific Wallstent Enteral Endoprosthesis recalled?
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
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?
Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
- Product
- Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
- Recalling firm
- SPS Sterilization, Inc
- Quantity
- 2 units total
- Distribution
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Recall date
- September 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)