Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
Check against the official notice below — it lists the full affected range.
SPS Sterilization, Inc. has recalled Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stents (10MM X 94MM, 135CM) that were resterilized. The problem is that the expiration dates printed on the device labels are longer than the actual validated shelf life of the devices because the sterilization process used does not adequately support an extended shelf life. Three units total were distributed across Arizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia, and West Virginia under lot numbers 17752073, 17752073, and 17422520 with serial numbers 21408032017-03, 21408032017-04, and 21408032017-05 (code number 71139-R).
The recall record does not specify a remedy or what affected consumers should do.
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 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.