Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. has recalled Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent devices (22MM X 90MM) that were resterilized. The recall affects two units distributed across Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The devices involved are Lot Number 17252887 (Serial Number 16211282016-02) and Lot Number 17465176 (Serial Numbers 97403172017-16 and 97403172017-40), all bearing Code Number 6559-R.
The reason for the recall is that the expiration date printed on the device labeling exceeds the actual validated shelf life of the product. The sterilization process used does not have adequate support for the extended shelf life claimed on the label. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV Quantity: 2 units total Lot/code info: Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.