medical Class II Updated 2018-09-19

SPS Sterilization, Inc recalls Edwards Lifesciences Thin-Flex Single Stage Venous Drainage

Recalled Product

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, FL, OH, PA, TX, VA, WV
Lot/Code Info: Code Number TF038L-R; Lot Number 59634935; Serial Numbers 18302172017-01, 18302172017-02, 18302172017-03, 18302172017-04, 18302172017-05, 18302172017-06, 18302172017-07, 18302172017-08, 18302172017-09, 18302172017-10
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →