Device Recall Stryker PainPump

  • Model / Serial
    Lot Number: 2008011403, 2008020502, 2008061701 and 2008072102.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product Number 0500-166-025, REF 500-166-25. || A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

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