Device Recall WOLFPAK, Medpro, Vipat

  • Model / Serial
    AccuFlux, Lot#: 91209.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the state of IL
  • Product Description
    Medpro Elastomeric Infusion Pump. || AccuFlux, Model # CT-0020-100H. || Product Usage: || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    First Medical Source LLC, 28581 Springfield Dr, Laguna Beach CA 92677-1424
  • Manufacturer Parent Company (2017)
  • Source
    USFDA