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

Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Code information: Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 N/A BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 N/A HMO 51100-USA 701067938 N/A HMO 70100-USA 701067874 N/A HMO 71100-USA 701067886 N/A All lots

Distribution pattern: Nationwide domestic distribution