Smiths Medical ASD, Inc.: CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-21

Hazard

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Details from the source

Reason for recall: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. Distribution: Worldwide - US nationwide distribution. Quantity: 185,975 US; 127,701 OUS Total Lot/code info: All CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps UDI-DI: 10610586034787 10610586038778 10610586038785 10610586038808 10610586038822 10610586039232 10610586041037 10610586041051 10610586042591 10610586042669 10610586042829 10610586042836 15019517084368 15019517096378 15019517096385 15019517096392 15019517099690 15019517101003 15019517101010 15019517101034 15019517101041 15019517126587 15019517126594 15019517126600 15019517126617 15019517128697 15019517135343 15019517149999 15019517150001 15019517150292 15019517154290 15019517154887 15019517154924 15019517154979 15019517154986 15019517154993 15019517155006 15019517155013 15019517155044 15019517246735 15019517247008 15019517247169 15019517247176 15019517247183 15019517247206 00610586038900 00610586039310 04546027095620 04546027095637 04546027095644 04546027095668 04546027095675 04546027095682 04546027095699 04546027095705 04546027095712 04546027095729 04546027095736 04546027095743 04546027095897 04546027095903 04546027095910 04546027422983 04546027424116 04546027424130 04546027424147 04546027424178 04546027424185 04546027424192 04546027424208 04546027424598 05019517154934 05019517155108 10610586031854 10610586033933 10610586033940 10610586035067 10610586035357 10610586035395 10610586035401 10610586035418 10610586035432 10610586035456 10610586035494 10610586038501 10610586038518 10610586038792 10610586038839 10610586038860 10610586038891 10610586038914 10610586038921 10610586038938 10610586038952 10610586038969 1061058

UPC codes

10610586034787, 10610586038778, 10610586038785, 10610586038808, 10610586038822, 10610586039232, 10610586041037, 10610586041051, 10610586042591, 10610586042669, 10610586042829, 10610586042836, 15019517084368, 15019517096378, 15019517096385, 15019517096392, 15019517099690, 15019517101003, 15019517101010, 15019517101034, 15019517101041, 15019517126587, 15019517126594, 15019517126600, 15019517126617, 15019517128697, 15019517135343, 15019517149999, 15019517150001, 15019517150292, 15019517154290, 15019517154887, 15019517154924, 15019517154979, 15019517154986, 15019517154993, 15019517155006, 15019517155013, 15019517155044, 15019517246735

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.