Events

Recall of Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.

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
    56687
  • Event Risk Class
    Class 2
  • Event Number
    Z-0097-2011
  • Event Initiated Date
    2010-08-16
  • Event Date Posted
    2010-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94282
  • 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
    The instructions for use (ifu) has been revised for health care professionals. the indication for use has been changed to remove site specific pain management. the firm has revised the warning to not use the pump around joint spaces. a warning has been added regarding the use of the pump with anticoagulants in epidural applications. a special reminder to users to always evaluate the potential.
  • Action
    Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.

Device

Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stry...
  • Model / Serial
    09162012, '09163012, '09208012, '09215012, '09223012, '09232012, '09238012, '09246012, '09259012, '09266012, '09280012, '09287012, '09300012, '09303012, '09351012, '09352012, '09353012, '09355022, '09356012, '09362022, '10005012, '10007012, '10008012, '10011012, '10047012, '10048012, '10049012, '10050012, '10074022, '10076012, '10077012, '10078012, '10081022, '10102022, '10103012, '10104012, '10105012, '10106012, '10109022, '10110012, '10111022, '10112032, '10113012, '10116022, '10117012, '10118012, '10119012, '10120012, '10123022, '10124012, '10153012, '10154012 and '10155012.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, Canada and Australia.
  • Product Description
    Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
  • 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., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA