Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. has recalled Vascular Solutions Venture Rx Catheters, 6F, that were resterilized. The devices were distributed in the United States to Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. A total of 3 units were affected, identified by Code Number 5820-R with Lot Numbers 570183 and 583022.
The recall was issued because the expiration dates printed on the device labeling exceed the actual validated shelf life of the products. The sterilization process used does not have adequate support for the extended shelf life claimed on the labeling. The source document 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: 3 units total Lot/code info: Code Number 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.