Events

Recall of Device Recall Stryker PainPump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50184
  • Event Risk Class
    Class 2
  • Event Number
    Z-0923-2009
  • Event Initiated Date
    2008-11-07
  • Event Date Posted
    2009-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    There is a potential for the pump to overinfuse.
  • Action
    A "Medical Device Recall Notification" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808.

Device

Device Recall Stryker PainPump
  • Model / Serial
    Lot Number: 2008011403, 2008020502, 2008061701 and 2008072102.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

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