Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. is recalling 10 units of Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, model 38FRX40CM, that were resterilized. The devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The affected lot is Code Number TF038L-R, Lot Number 59634935, consisting of serial numbers 18302172017-01 through 18302172017-10.
The reason for the recall is that the expiration date printed on the device labeling exceeds the actual validated shelf life of the product because the sterilization process used does not have adequate support for the extended shelf life. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 10 units total 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.