Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid ...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1978-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing periph...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1967-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are i...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1974-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFl...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1983-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1985-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid P...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1987-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid P...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1988-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wi...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1975-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PAS...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1969-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with P...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1977-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in esta...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1972-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV a...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1980-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated ...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1966-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC w...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1981-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wi...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1976-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFl...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1982-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wit...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1986-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are ...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1973-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous ...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1971-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hyb...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1979-2016June 22, 2016Glens Falls, NY
Excelsior Medical Corp
Class IITerminated
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
Reason: Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
Z-1989-2016June 22, 2016Neptune, NJ
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC wi...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1984-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC ...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Z-1970-2016June 22, 2016Glens Falls, NY
Navilyst Medical, Inc., an AngioDyamics Company
Class IITerminated
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for...
Reason: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling thr...
Reason: It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405...