Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133

Reason: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Code information: Batch Numbers: 3000044424 3000046488 3000049459 3000055093 3000060357

Distribution pattern: Nationwide