# FDA recall Z-2544-2021

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2021-08-10.

## Product

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid  Material ID: 354212

## Reason for recall

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

## Distribution

Worldwide distribution - US Nationwide distribution and the country of Canada.

## Key facts

- **Recall number:** Z-2544-2021
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-10
- **Report date:** 2021-10-06
- **Termination date:** 2024-09-16

- **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-2544-2021

## Citation

> AI Analytics. FDA recall Z-2544-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2544-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*