Class II — Bayer Medical Care, Inc.
| Recalling firm | Bayer Medical Care Inc. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Black specks may be present on the packaged needles |
| 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. |
| Quantity | 2840 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China. |
| Initiated | 2022-11-30 |
| Classified | 2023-01-06 |
| Recall number | Z-0910-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bayer Medical Care, Inc. (Z-0910-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91273/
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