Events

Recall of PainPump2

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
    56695
  • Event Risk Class
    Class 2
  • Event Number
    Z-2592-2010
  • Event Initiated Date
    2010-09-02
  • Event Date Posted
    2010-09-28
  • 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=94301
  • 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
    Infusion Pump - Product Code FRN
  • Reason
    All of the failures lead to the patient receiving less medication than intended. certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. some lots have a high failure rate associated with e2 errors.
  • Action
    The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product. On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year -so the recall was for all product currently in the supply chain. The letter again directed consignees to locate the recalled products and contact Stryker to arrange return shipment of the recalled product. The firm sent an additional letter dated 9/1/2010 to its customers. This letter stated that Stryker will no longer be offering any of their PainPump2 products.

Device

PainPump2
  • Model / Serial
    09232012, '10112032, '09238012, '10113012, '09246012, '10116022, '09259012, '10117012, '09266012, '10118012, '09280012, '10119012, '09287012, '10120012, '09300012, '10123022, '09303012, '10124012, '10005012, '10153012, '10007012, '10154012, '10008012, '10155012, '10011012, '10158022, '10047012, '10159012, '10048012, '10160012, '10049012, '10161012, '10050012, '10162012, '10074022, '10165022, '10076012, '10166012, '10077012, '10167012, '10078012, '10167022, '10081022, '10168012, '10102022, '10169012, '10103012, '10170012, '10104012, '10172022, '10105012, '10173012, '10106012, '10174012, '10109022, '10175012, '10110012, '10176012, '10111022, and '10177012.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, and Australia.
  • Product Description
    Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI. || Delivers controlled amounts of medication and narcotics.
  • 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