Navilyst Medical, Inc., an AngioDyamics Company

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1982-2016Class IIBioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458March 14, 2016
Z-1985-2016Class IIBioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The March 14, 2016
Z-1980-2016Class IIXcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPNMarch 14, 2016
Z-1984-2016Class IIBioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY ThMarch 14, 2016
Z-1966-2016Class IIVaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4FMarch 14, 2016
Z-1974-2016Class IIXcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC March 14, 2016
Z-1972-2016Class IIVaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370,March 14, 2016
Z-1970-2016Class IIVaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, March 14, 2016
Z-1967-2016Class IIVaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2)March 14, 2016
Z-1969-2016Class IIVaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, March 14, 2016
Z-1971-2016Class IIVaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY TheMarch 14, 2016
Z-1977-2016Class IIXcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The XcMarch 14, 2016
Z-1975-2016Class IIXcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY ThMarch 14, 2016
Z-1987-2016Class IIBioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONMarch 14, 2016
Z-1973-2016Class IIXcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICCMarch 14, 2016
Z-1976-2016Class IIXcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY ThMarch 14, 2016
Z-1986-2016Class IIBioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY TheMarch 14, 2016
Z-1979-2016Class IIXcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, March 14, 2016
Z-1983-2016Class IIBioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458March 14, 2016
Z-1978-2016Class IIXcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx OMarch 14, 2016