Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) 의 리콜

Recall

79177

Class 2

Z-0971-2018

2017-10-06

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161516

Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.

An Urgent Medical Device Correction, dated October 6, 2017, was sent to customers. The letter described the problem, identified the affected device, discussed the hazard involved, and action to be taken. Customers were asked to locate the affected products at their facility. Customers should continue to follow the instructions in document 41394 Rev. A, PREVENTIVE MAINTENANCE, for their entire fleet of pumps. Baxter will inspect affected pumps. To arrange for return of devices that have failed the flow rate accuracy test, contact Baxter Healthcare Medina. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Urgent Medical Device Correction. If there are additional questions, customers can contact their Baxter Sales Rep or Baxter Healthcare Medina at 800-356-3454.