Device Recall Vaxcel PICC with PASV IR145 Kit

  • Modèle / numéro de série
    Batch/Lots: 1) 4748893, 4766101, 4773293 & 4814220 with Use By Range 2016-05-31 to 2016-10-31.  Batch/Lots: 2) 4752348, 4784466, 4735032, 4738833, 4765395 & 4814222 with Use By Range 2016-05-31 to 2016-07-31.  Batch/Lots: 3) 4752881, 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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 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

Fabricant

  • Adresse du fabricant
    Navilyst Medical, Inc., an AngioDyamics Company, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Société-mère du fabricant (2017)
  • Source
    USFDA