FDA Device recall Z-0355-2024
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site
- FDA Device
- Class I
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class I recall of Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site by B Braun Medical, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0355-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-01 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
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; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 15 drops/mL, priming volume: 26mL, length: 124in, SafeLine; 362420 SPACE PUMP SET 15 DROP W/2 SAFEDAY; 362432 15 drops/mL, priming volume: 21mL, length: 118in, ULTRASITE; 362911 Priming volume: 14mL, length: 84in, CARESITE, Spin-Lock; 363010 Priming volume: 21mL, length: 121in, SafeLine; 363019 Priming volume: 40mL, length: 123in, SafeLine; 363030 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 363032 20 drops/mL, priming volume: 20mL, length: 119in, SafeLine; 363230 15 drops/mL, priming volume: 22mL, length: 123in, ULTRASITE; 363410 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 363419 Priming volume: 41mL, length: 120in, CARESITE; 363420 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 363421 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 363422 Priming volume: 21mL, length: 130in, CARESITE; 363423 60 drops/mL, priming volume: 21mL, length: 118in, CARESITE; 363424 UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV; 363430 15 drops/mL, priming volume: 23mL, length: 123in, CARESITE; 363433 UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV; 363901 60 drops/mL, priming volume: 11mL, length: 129in; 363902 Priming volume: 25mL, length: 130in; 363904 UNIV. 15 DROP PUMP SET, ASV; 470119 15 drops/mL, priming volume: 23mL, length: 119in, CARESITE; 480254 SPACE PUMP IV SET 15D, 110 IN.; 480255 SPACE PUMP IV SET, 127 IN; 480257 60 DROP NITRO SPACE SET, 88 IN.; 480258 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER; 480263 SPACE PUMP IV SET 15D, 90 IN.; 480264 SPACE PUMP IV SET, 15 DRPS/ML, 95 IN.; 490037 Priming volume: 25mL, length: 136in; 490038 60 drops/mL, priming volume: 11mL, length: 129in; 490100 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490101 Priming volume: 19mL, length: 120in, CARESITE; 490102 15 drops/mL, priming volume: 22mL, length: 120in, CARESITE; 490103 15 drops/mL, priming volume: 24mL, length: 120in, CARESITE; 490104 60 drops/mL, priming volume: 21mL, length: 115in, CARESITE; 490105 Priming volume: 39mL, length: 120in, CARESITE
Reason
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.
Identifiers
| code_info | Material No. 362031 UDI-DI 04046964837807 Lots: 0061809812 0061822006 0061826547 0061842006 0061844316 0061850548 00618…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: 006182200 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0355-2024%22
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