# FDA recall Z-0355-2024

> **B. Braun Medical, Inc.** · Class I · device recall initiated 2023-11-01.

## 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, lengt

## 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.

## Key facts

- **Recall number:** Z-0355-2024
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-01
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0355-2024

## Citation

> AI Analytics. FDA recall Z-0355-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0355-2024. Source: US FDA. Licensed CC0.

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