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Recall Observatory FDA recall evidence

Device product

Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.

Z-3031-2018

March 07, 2018

Class II

Product summary

Firm
SPS Sterilization, Inc
Event
Event 80317
Status
Terminated
Classification
Class II
Quantity
5 units total
Official record key
device-enforcement:Z-3031-2018

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 TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06

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.