medical Class II Updated 2018-09-19

SPS Sterilization, Inc recalls Boston Scientific Wallstent Enteral Endoprosthesis Colonic/D

Recalled Product

Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, FL, OH, PA, TX, VA, WV
Lot/Code Info: Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
View official government recall

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