Bayer Medical Care, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0910-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 30, 2022

Date Posted: January 18, 2023

Recall Number: Z-0910-2023

Event ID: 91273

Reason for Recall:

Black specks may be present on the packaged needles

Status: Ongoing

Product Quantity: 2840 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated