Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. has recalled Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula devices (34F, 11.3MM X 40CM) that were resterilized. The recall affects five units with Code Number TF034L-R and Lot Number 59739865 (Serial Numbers 18304192017-12 through 18304192017-16) that were distributed to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. The devices were recalled because the expiration date on the labeling exceeds the actual validated shelf life, as the sterilization process used does not have adequate support for the extended shelf life claimed.
The recall record does not specify a remedy or instructions 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: 5 units total Lot/code info: Code Number TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.