Device Recall Vaxcel PICC with PASV Catheter Kit

  • Model / Serial
    Batch/Lots: 1) 4732402, 4745359, 4824107, 4827333, 4835750, 4860987 & 48698433, 2) 4772713, 4786763, 4790018, 4817452 & 3) 4725793, 4745367, 4748673, 4756297, 4765394, 4773295, 4784468, 4788536 & 4845665 with Use By 2016-04-30.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    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 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Navilyst Medical, Inc., an AngioDyamics Company, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
  • Source
    USFDA