FDA recall Z-3030-2018

Product

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), 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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-03-07

Report date

2018-09-19

Termination date

2018-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nixa, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3030-2018