3,445 results found for catheter
Page 35 of 138
ZOLL Circulation, Inc.
Class II Terminated FDA Details
ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)0084911107521...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)0084911107553...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL Circulation, Inc.
Class II Terminated FDA Details
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, St...
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
IMPERATIVE CARE INC
Class I Completed FDA Details
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Reason: There is a potential for distal end of catheters to fracture and become detached.
C.R. Bard Inc
Class II Ongoing FDA Details
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Reason: There is potential for packaging defects that may impact the sterile barrier.
Medtronic Perfusion Systems
Class II Ongoing FDA Details
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Reason: Potential for a wire protrusion through the left heart vent catheter tip
C.R. Bard Inc
Class II Ongoing FDA Details
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Reason: There is potential for packaging defects that may impact the sterile barrier.
C.R. Bard Inc
Class II Ongoing FDA Details
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Reason: There is potential for packaging defects that may impact the sterile barrier.
Medtronic Perfusion Systems
Class II Ongoing FDA Details
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Reason: Potential for a wire protrusion through the left heart vent catheter tip
C.R. Bard Inc
Class II Ongoing FDA Details
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Reason: There is potential for packaging defects that may impact the sterile barrier.
Cordis Corporation
Class I Terminated FDA Details
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular d...
Cordis Corporation
Class I Terminated FDA Details
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular d...
Cordis Corporation
Class I Terminated FDA Details
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular d...
Cordis Corporation
Class I Terminated FDA Details
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular d...
Cordis Corporation
Class I Terminated FDA Details
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular d...
Mivi Neuroscience Inc
Class II Terminated FDA Details
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is use...
Reason: There is potential for nonsterility of product due to a possible defect in the pouch seal.