Device evidence

device-recall:cfres:200680

QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

Official recall number

Z-1643-2023

Evidence summary

Product code: DTQ
Recall status: Open, Classified
Event initiated: May 18, 2023
Root cause: Pending
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1643-2023