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Terminated

Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

FDA Recall Z-3034-2018 · Posted None

Recalling FirmSPS Sterilization, Inc
Recall StatusTerminated
Product CodeDQR
Date Initiated2018-03-07
Date Terminated2018-11-27
Product Quantity1 unit total

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.

Firm Action

Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.

Root Cause

Labeling False and Misleading

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research Medical · 2008-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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