Brainlab AG - Spine & Trauma 3D 2.0 - Class 2 Recall
Spine & Trauma 3D 2.0 is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to...
View ArticleCodman & Shurtleff, Inc. - CODMAN CERTAS Programmable Valves - Class 2...
CODMAN¿ CERTAS" Programmable Valves, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories...
View ArticleOrtho-Clinical Diagnostics - VITROS Chemistry Products CRBM Slides - Class 2...
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 and Ortho-Clinical Diagnostics High Wycombe, UK HP12 4DP. For in vitro diagnostic use...
View ArticleRemel Inc - Oxoid Legionella Latex Test - Class 2 Recall
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm...
View ArticleBioMerieux SA - FB Reagent (REF 70562) - Class 2 Recall
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips...
View ArticleBioMerieux SA - API Listeria (REF 10300) - Class 2 Recall
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API s are standardized systems combining several biochemical tests that...
View ArticleBioMerieux SA - API NIH (REF 10400) - Class 2 Recall
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable...
View ArticleBioMerieux SA - ZYM B Reagent (REF 70493) - Class 2 Recall
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized...
View ArticleRemel Inc - Oxoid Legionella Pneumo Groups 214 - Class 2 Recall
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The...
View ArticlePega Medical Inc. - FassierDuval IM Telescopic Stsyem - Class 2 Recall
Fassier-Duval IM Telescopic System. This is an implant size of the Fassier-Duval IM Telescope System -Duval IM Telescopic System.
View ArticleRAYSEARCH LABORATORIES AB - Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0 - Class 2...
Radiation Therapy Treatment Planning System, Stand-alone software. Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans...
View ArticleGE Healthcare, LLC - GE Healthcare, Discovery MR450, Discovery MR750, Optima...
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products.
View ArticleHospira Inc. - LifeShield HemoSet I.V. PlumSet - Class 2 Recall
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use...
View ArticleAbbott Molecular - CEP 8 (D8Z2) SpectrumGreen Probe - Class 3 Recall
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA)....
View ArticleMerit Medical Systems, Inc. - Merit Laureate Hydrophilic Guide Wire - Class 2...
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
View ArticleMerit Medical Systems, Inc. - Merit Laureate Hydrophilic Guide Wire - Class 2...
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
View ArticleBoston Scientific Corporation - iLab Ultrasound Imaging System - Class 2 Recall
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Product Usage: The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular...
View ArticleGE Healthcare, LLC - GE Ultrasound Vivid E9 - Class 2 Recall
GE Ultrasound Vivid E9 Product Usage: GE Vivid E9 Ultrasound System is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of,...
View ArticleEv3, Inc. - EverCross 0.035 OTW PTA Dilatation Catheter - Class 2 Recall
ev3 EverCross 0.035" OTW PTA Dilatation Catheter Sterilized using Ethylene Oxide, 6mm x 120mm x 135cm, REF: AB35W06120135. ev3 EverCross 0.035" OTW PTA Dilatation Catheter Sterilized using Ethylene...
View ArticleOrtho-Clinical Diagnostics - VITROS Chemistry Products CDM PROM - Class 2 Recall
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721,...
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