Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. is recalling Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula devices (29/37F size, 37cm length) that were resterilized. The devices have expiration dates on their labels that go beyond the actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life claimed. Five total units were distributed across Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia under Code Number TF293702-R, Lot Number 59655659, with serial numbers 18304192017-02 through 18304192017-06.
The recall record does not specify a remedy or recommended action 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 TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.