Device Recall BCare 5 의 리콜

Recall

56139

Class 2

Z-2074-2010

2010-06-18

2010-07-22

Terminated

United States

2010-07-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92729

Although accessories were designed for use with two models, the hlm c5 and the hlm s5, the submission that included references to the mast roller pump, b-care5, and the electrical venous line occluder accessories covered the new hlm s5 system. the three accessories were not cleared for use with the hlm c5.

The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.