# FDA recall Z-0509-2021

> **Janus Trade Group** · Class II · device recall initiated 2020-03-23.

## Product

B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01  4252519-01  4252535-01  4252560-01  4252586-01  4251890-01  4252535-01  4252586-01  4251644-01

## Reason for recall

Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

## Distribution

US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

## Key facts

- **Recall number:** Z-0509-2021
- **Recalling firm:** Janus Trade Group
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-23
- **Report date:** 2020-12-09
- **Termination date:** 2021-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eatontown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2021

## Citation

> AI Analytics. FDA recall Z-0509-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0509-2021. Source: US FDA. Licensed CC0.

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