Home / Recalls / Bayer Medical Care, Inc. / Z-0910-2023

Z-0910-2023 Class II Ongoing

Recalled by Bayer Medical Care, Inc. — Indianola, PA

Recall Details

Product Type
Devices
Report Date
January 18, 2023
Initiation Date
November 30, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2840 units

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

Distribution Pattern

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

Code Information

UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023

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  • Z-0097-2019 Class II — Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administrati (September 7, 2018)
  • Z-2960-2018 Class II — Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalo (June 28, 2018)
  • Z-2961-2018 Class II — Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Ba (June 28, 2018)
  • Z-2962-2018 Class II — Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalo (June 28, 2018)