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All Recalls

Every Navilyst Medical, Inc Recall

Sorted by most recent. Click any recall for full details.

48 recalls
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Li...
Medical Devices·602 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Li...
Medical Devices·133 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device L...
Medical Devices·22 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·74 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·489 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Li...
Medical Devices·30 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·17 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·2,502 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- Fo...
Medical Devices·438 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Li...
Medical Devices·7 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·390 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D1...
Medical Devices·238 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·124 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Devic...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- De...
Medical Devices·16 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only. Dev...
Medical Devices·19 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number...
Medical Devices·1,008 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D13...
Medical Devices·4 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. ...
Medical Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·61 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·541 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·69 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·13 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·20 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Lis...
Cardiac Devices·2,409 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device List...
Medical Devices·70 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---...
Cardiac Devices·105 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·161 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·562 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·136 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Lis...
Medical Devices·10 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device ...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D1...
Medical Devices·260 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236, STERILE, Rx ONLY --- For single use only. Device L...
Medical Devices·32 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY --- For single use only. --- Device Listing Number ...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catal...
Medical Devices·54 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices·3 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE ---...
Medical Devices·65 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices·3 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catal...
Medical Devices·300 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0...
Medical Devices·60 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1...
Medical Devices·45 affected·Aug 25, 2014
High RiskFDA
Navilyst Medical, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; ...
Medical Implants·920 affected·Nov 25, 2013