Recall Z-3031-2018— SPS Sterilization, Inc

Name: FDA recall Z-3031-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-07

Class II · Terminated

Class II FDA medical device recall by SPS Sterilization, Inc, initiated 2018-03-07, terminated 2018-11-27. It names one FDA 510(k) clearance: K120072. Product: Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.. 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..

Recalling firm: SPS Sterilization, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-07
Terminated: 2018-11-27
Firm location: Nixa, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K120072 — VENOUS DRAINAGE CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC·cleared 2012-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.