Home / Recalls / Navilyst Medical, Inc., an AngioDyamics Company / Z-1967-2016

Z-1967-2016 Class II Terminated

Recalled by Navilyst Medical, Inc., an AngioDyamics Company — Glens Falls, NY

Recall Details

Product Type
Devices
Report Date
June 22, 2016
Initiation Date
March 14, 2016
Termination Date
June 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
328 units

Product Description

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 peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

Reason for Recall

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 through the PICC catheter.

Distribution Pattern

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

Code Information

Batch/Lots:1) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.

Other recalls by Navilyst Medical, Inc., an AngioDyamics Company

  • Z-1985-2016 Class II — BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, (March 14, 2016)
  • Z-1980-2016 Class II — Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, (March 14, 2016)
  • Z-1984-2016 Class II — BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965 (March 14, 2016)
  • Z-1966-2016 Class II — Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96545 (March 14, 2016)
  • Z-1974-2016 Class II — Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx O (March 14, 2016)
  • Z-1972-2016 Class II — Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) (March 14, 2016)
  • Z-1970-2016 Class II — Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654543 (March 14, 2016)
  • Z-1969-2016 Class II — Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M0014545 (March 14, 2016)
  • Z-1971-2016 Class II — Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001 (March 14, 2016)
  • Z-1982-2016 Class II — BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965 (March 14, 2016)