Recall Z-0910-2023— Bayer Medical Care, Inc.

Name: FDA recall Z-0910-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-30

Class II · Ongoing

Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2022-11-30. It names one FDA 510(k) clearance: K100798. 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: Black specks may be present on the packaged needles.

Recalling firm: Bayer Medical Care, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-30
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT CMedrad, Inc.·cleared 2010-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.