| 2022-11-30 |
Class II
|
Ongoing |
Z-0910-2023 |
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affec… |
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Black specks may be present on the packaged needles |
| 2021-09-14 |
Class II
|
Terminated |
Z-0199-2022 |
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate materi… |
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Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) |
| 2020-10-05 |
Class II
|
Terminated |
Z-0483-2021 |
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS … |
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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. |