Richard-Allan Scientific Company - 10 NBF - Class 1 Recall
Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis...
View ArticleArrow International Inc - Arrow Select Kits (ASK) and Maximal Barrier...
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Poilus 10mL Saline Flush Syringe multiple, see attachment A of the 806 report for complete intended use descriptions...
View ArticleStryker Howmedica Osteonics Corp. - Class 2 Recall
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide...
View ArticleInvivo Corporation - Expression MR200 MRI Patient Monitoring System - Class 2...
Philips Expression MR200 MRI Patient Monitoring System
View ArticleKCI USA, Inc. - V.A.C. GranuFoam Silver Dressing - Class 2 Recall
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
View ArticleMerge Healthcare, Inc. - eFilm Workstation - Class 2 Recall
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is...
View ArticlePrimus Medical LLC - Prime Care Bed PCB900 - Class 2 Recall
AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
View ArticleIntuitive Surgical, Inc. - da Vinci Si Surgical System - Class 2 Recall
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended...
View ArticleOrtho-Clinical Diagnostics - VITROS 4600 Chemistry System - Class 2 Recall
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a...
View ArticleArrow International Inc - Arrow MultiLumen Central Venous Catheterization -...
Multi-Lumen Central Venous Catheterization Kit
View ArticleOrtho-Clinical Diagnostics - VITROS 5600 Integrated System - Class 2 Recall
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using...
View ArticleBiomet, Inc. - Elbow Humeral Trial - Class 2 Recall
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications....
View ArticleAmeditech Inc - ArcPoint Labs 10 Panel Dip Screen (OXY) - Class 2 Recall
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in...
View ArticleAmeditech Inc - ArcPoint Labs 5 Panel Dip Drug Screen - Class 2 Recall
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in...
View ArticleAmeditech Inc - ArcPoint Labs 10 Panel Dip Screen (BAR) - Class 2 Recall
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in...
View ArticleArjo, Inc. dba ArjoHuntleigh - Maxi Sky 2 Medium 2Point Spreader Bar - Class...
Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.
View ArticleSiemens Healthcare Diagnostics, Inc - Clinitek Status - Class 2 Recall
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
View ArticleSiemens Healthcare Diagnostics, Inc - Clinitek Status - Class 2 Recall
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
View ArticleSiemens Healthcare Diagnostics, Inc - Clinitek Status - Class 2 Recall
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
View ArticleSiemens Medical Solutions USA, Inc - Siemens Mammomat Inspiration mammography...
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical...
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