International Medical Devices Database

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
52163
Event Risk Class
Class 2
Event Number
Z-1829-2009
Event Initiated Date
2009-05-14
Event Date Posted
2009-09-04
Event Status
Terminated
Event Country
United States
Event Terminated Date
2010-01-20
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82308
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 for pain medication. - Product Code MEB
Reason
Failure to infuse and potential compromised sterility: the seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
Action
Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.

Device

Device Recall Stryker 100 mL AutoFuser PainPump

Model / Serial
Lots 08142756096 through 09009869153.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada.
Product Description
Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000.
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

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of Device Recall Stryker 100 mL AutoFuser PainPump

What is this?

Device

Device Recall Stryker 100 mL AutoFuser PainPump

Manufacturer

Stryker Instruments Div. of Stryker Corporation