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Recall Observatory FDA recall evidence

Device product

Vascular Solutions Venture Rx Catheter, 6F, resterilized.

Z-3041-2018

March 07, 2018

Class II

Product summary

Firm
SPS Sterilization, Inc
Event
Event 80317
Status
Terminated
Classification
Class II
Quantity
3 units total
Official record key
device-enforcement:Z-3041-2018

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 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)

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.