# FDA recall Z-0910-2023

> **Bayer Medical Care, Inc.** · Class II · device recall initiated 2022-11-30.

## Product

Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile  Catalog number: INT CSS  Affected material number: 86566621     Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET   Positron Emission Tomography - nuclear medicine) diagnostic procedures.

## Reason for recall

Black specks may be present on the packaged needles

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.

## Key facts

- **Recall number:** Z-0910-2023
- **Recalling firm:** Bayer Medical Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-30
- **Report date:** 2023-01-18

- **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-0910-2023

## Citation

> AI Analytics. FDA recall Z-0910-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0910-2023. Source: US FDA. Licensed CC0.

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