Device Recall Vaxcel PICC with PASV MST60 Kit

  • Model / Serial
    Batch/Lots: 1) 4724945, 4731137, 4738296, 4895232, 4912062, 4933353, 2) 4731139, 4738302, 4748674, 4776152, 3) 4721239, 4784467, 4810672, 4812161, 4821239, 4821511, 4824106, 4830612, 4832722, 4836599, 4724949, 4724950, 4738298, 4738299, 4773297, 4773298, 4786764, 4823438, 4829478, 4832723,4845209, 4724926 & 4734253 with Use By Date Range 2016-03-31 to 2017-09-30.
  • 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 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 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