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Recall Observatory FDA recall evidence

Device product

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

Z-3038-2018

March 07, 2018

Class II

Product summary

Firm
SPS Sterilization, Inc
Event
Event 80317
Status
Terminated
Classification
Class II
Quantity
2 units total
Official record key
device-enforcement:Z-3038-2018

Official wording

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.

Code information: Code Number 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)

Distribution pattern: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.