Data Foundry

Medical device recalls 2023

Infusomat Administration Sets as listed below: 362031 Infusomat Space… — Class I medical device recall Z-0355-2024

Ongoing recall by B. Braun Medical, Inc., reported 2023-12-13, distributed nationwide. In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Bot

Recall numberZ-0355-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmB. Braun Medical, Inc., Allentown, PA, United States
Recall initiated2023-11-01
Classified2023-12-01
Reported by FDA2023-12-13
DistributedNationwide (US)
Countries outside the USCA, DE
Quantity33,820,976 units
UPC / GTIN / UDI-DI04046955324798, 04046955324804, 04046955324828, 04046955324835, 04046955592715, 04046955693931, 04046955778744, 04046964182556, 04046964182570, 04046964182631, 04046964182655, 04046964182679, 04046964185922, 04046964185946, 04046964186080, 04046964186103, 04046964186127, 04046964186141, 04046964186165, 04046964294174, 04046964294198, 04046964294259, 04046964294297, 04046964294495, 04046964294556 and 17 more
Lot numbers0061806560, 0061809812, 0061809813, 0061811558, 0061811559, 0061812951, 0061812953, 0061814341, 0061814343, 0061814344, 0061814346, 0061814347, 0061814358, 0061814994, 0061815234, 0061815235, 0061815236, 0061815238, 0061815242, 0061815247, 0061815254, 0061815266, 0061815475, 0061815476, 0061815478, 0061815480, 0061815482, 0061815484, 0061815489, 0061815493, 0061815495, 0061816433, 0061816434, 0061816435, 0061816436, 0061816472, 0061816474, 0061816796, 0061816798, 0061816799 and 460 more

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0355-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.