SPS Sterilization, Inc

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3041-2018Class IIVascular Solutions Venture Rx Catheter, 6F, resterilized.March 7, 2018
Z-3036-2018Class IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CMMarch 7, 2018
Z-3032-2018Class IIEdwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.March 7, 2018
Z-3034-2018Class IIEdwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.March 7, 2018
Z-3029-2018Class IIEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.March 7, 2018
Z-3040-2018Class IIBoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 1March 7, 2018
Z-3035-2018Class IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding StenMarch 7, 2018
Z-3038-2018Class IIBoston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilizedMarch 7, 2018
Z-3027-2018Class IIEdwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.March 7, 2018
Z-3028-2018Class IIEdwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.March 7, 2018
Z-3033-2018Class IIEdwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.March 7, 2018
Z-3030-2018Class IIEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), restMarch 7, 2018
Z-3039-2018Class IIBoston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding SMarch 7, 2018
Z-3031-2018Class IIEdwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), reMarch 7, 2018
Z-3037-2018Class IIBoston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CMMarch 7, 2018