# FDA recall Z-0819-2022

> **B Braun Medical Inc** · Class II · device recall initiated 2022-02-07.

## Product

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions  Catalog Number: 8713030U

## Reason for recall

Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in  therapy, overinfusion, or underinfusion.

## Distribution

US Distribution to states of: MA, VT

## Key facts

- **Recall number:** Z-0819-2022
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-07
- **Report date:** 2022-03-30
- **Termination date:** 2023-12-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2022

## Citation

> AI Analytics. FDA recall Z-0819-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0819-2022. Source: US FDA. Licensed CC0.

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