# FDA recall Z-0483-2021

> **Bayer Medical Care, Inc.** · Class II · device recall initiated 2020-10-05.

## Product

Brand Name: MEDRAD Stellant FLEX Syringe Kits    Common Name: Angiographic Syringe    Catalog/REF Number: FLEXD-150-SCS  Description:  2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube.    Catalog/REF Number: FLEXD-150-SPK  Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

## Reason for recall

Specific lots of MEDRAD Stellant FLEX  150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

## Distribution

Distributed to healthcare facilities nationwide throughout the US.

## Key facts

- **Recall number:** Z-0483-2021
- **Recalling firm:** Bayer Medical Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-05
- **Report date:** 2020-12-02
- **Termination date:** 2021-03-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2021

## Citation

> AI Analytics. FDA recall Z-0483-2021. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0483-2021. Source: US FDA. Licensed CC0.

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