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Recall Observatory FDA recall evidence

Device product

Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.

Z-3033-2018

March 07, 2018

Class II

Product summary

Firm
SPS Sterilization, Inc
Event
Event 80317
Status
Terminated
Classification
Class II
Quantity
1 unit total
Official record key
device-enforcement:Z-3033-2018

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 VFEM020-R; Lot Number 59691447; Serial Number 16704032017-01

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.