Source Administration Set medical device recalled for contamination
The FDA has recalled 2,840 units of the Source Administration Set, a medical device used for PET imaging, due to contamination with black specks on needles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no illnesses or injuries reported. Contamination on sterile injection needles represents a risk-of-harm product without reported injury, meeting the rubric criterion for High severity.
Plain-English summary
The FDA has recalled the Source Administration Set (SAS) used with the Medrad Intego PET Infusion System. Black specks may be present on the packaged needles.
This medical device is used to deliver radiopharmaceuticals during PET (Positron Emission Tomography) diagnostic imaging procedures for patients. The recall affects 2,840 units distributed worldwide, including U.S. states of Arizona, Indiana, Minnesota, New York, Ohio, Texas, Virginia, and China.
The affected batch is batch number 60272154, with expiration date December 9, 2023 (UDI: (01)00616258021478(11)201209(17)231209(10)60272154). The manufacturer is Bayer Medical Care, Inc.
The recalled product
- 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 commo
- Manufacturer
- Bayer Medical Care, Inc.
- Hazard
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2023
Distribution
Distributed nationwide across the United States.
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