Recall Z-3038-2018 ยท MQR Stent, Colonic, Metallic, Expandable
SPS Sterilization, Inc
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
| Date | Mar 7, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| Action | Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same. |
| Quantity | 2 units total |
| Distribution | US distribution to AZ, CA, FL, OH, PA, TX, VA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM Boston Scientific Corp, Sep 30, 2004 |