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Bayer Medical Care, Inc. FDA Recalls
4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;Class IIJul 31, 2026Some devices may not have been properly sterilized due to a |
| Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection SystemClass IIApr 24, 2026Supplier changes resulted in a fit issue with the Contrast F |
| Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS AffecClass IINov 30, 2022Black specks may be present on the packaged needles |
| The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate materiClass IISep 14, 2021Labeling error: MEDRAD Mark 7 Arterion Injection System Syri |