Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affec
Summary
The FDA issued a Class II for Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, by Bayer Medical Care, Inc.. Reason: Black specks may be present on the packaged needles.
Details
Source
Device Recall
External ID
Z-0910-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023
Quantity Affected: 2840 units
Reason for Recall
Black specks may be present on the packaged needles
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-30
Company
Indianola, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bayer Medical Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Medical Care, Inc. have FDA actions?
Bayer Medical Care, Inc. has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0910-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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