Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired....Read More

Company: Technidata S.A. Date of Enforcement Report: 7/24/2013 Class llI: PRODUCT TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) Recall Number Z-1743-2013 REASON A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/24/2013 Class ll: PRODUCT RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of...Read More