Device Recall Colleague CX Volumetric Infusion Pump 의 리콜

Recall

57515

Class 2

Z-0931-2011

2010-12-01

2011-01-21

Terminated

United States

2011-05-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96445

While the infusion pump was being serviced at the baxter service center, it was inadvertently routed to the packaging area before the final inspection.

Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.