Device Recall Colleague 3 and 3 CX Infusion Pumps 의 리콜

Recall

58806

Class 2

Z-2796-2011

2011-05-04

2011-07-13

Terminated

United States

2017-01-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100335

The air in line (ail) test was not properly performed by the service technician at the service center.

Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost. Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.