B. Braun Medical, Inc.: Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine;

Hazard

In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

Details from the source

Reason for recall: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death. Distribution: Distribution US nationwide, Canada and Germany. Quantity: 33,820,976 units Lot/code info: Material No. 362031 UDI-DI 04046964837807 Lots: 0061809812 0061822006 0061826547 0061842006 0061844316 0061850548 0061863075 00VL881443 00VL881444 00VL881445 Material No. 362032 UDI-DI 04046964182556 Lots: 0061825440 0061826518 0061841107 0061859898 0061891206 00VL881446 00VL881447 00VL881448 Material No.362033 UDI-DI 04046964837821 Lots: 0061825491 0061832933 0061841016 0061844319 0061852088 0061859899 0061861528 0061880107 0061888294 0061891613 0061900150 Material No. 362034 UDI-DI 04046964182570 Lots: 0061809813 0061875347 0061880110 0061895436 00VL845496 Material No. 362035 UDI-DI 04046964699047 Lots: 0061815242 0061820766 0061821992 0061821993 0061826531 0061829597 0061831769 0061832958 0061844310 0061847255 0061853102 0061855700 0061863625 0061888327 0061894407 Material No. 362043 UDI-DI 04046964182631 Lots: 0061863076 362050 04046964182655 0061822091 0061840508 0061852666 0061861244 00VL881402 00VL881403 00VL881404 Material No. 362420 UDI-DI 04046955592715 Lots: 0061822004 0061823035 0061823071 0061826688 0061831761 0061837001 0061837884 0061837891 0061842996 0061843033 0061847222 0061849999 0061855839 0061855840 0061859988 0061859990 0061859991 0061874588 0061876229 0061880059 0061883209 0061885064 0061888323 0061891571 0061892316 0061895535 0061895682 0061898768 0061898950 00VL880878 00VL882007 00VL882008 Material No. 362432 UDI-DI 04046964182679 Lots 0061806560 0061864982 Material No. 362911 UDI-DI 04046964837845 Lots 0061829592 0061847275 0061852087 0061855702 0061

UPC codes

04046964837807, 04046964182556, 04046964837821, 04046964182570, 04046964699047, 04046964182631, 04046964182655, 04046955592715, 04046964182679, 04046964837845, 04046964294174, 04046964294198, 04046964294259, 04046964294297, 04046964294495, 04046964294556, 04046964294570, 04046964294594, 04046964294617, 04046964294631, 04046964294655, 04046964837906, 04046964294679, 04046964837920, 04046964294716, 04046964294730, 04046964699061, 04046964298714, 04046955324798, 04046955324804, 04046955324828, 04046955324835, 04046955693931, 04046955778744, 04046964185922, 04046964185946, 04046964186080, 04046964186103, 04046964186127, 04046964302107

Source

Official record: FDA (Device enforcement) ↗

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