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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Bayer Medical Care, Inc.
- Hazard
- Affected units
- 2,840
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
Related recalls
Same manufacturer · Bayer Medical Care, Inc.
See all →- HighBayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues
FDA (Devices) · 2026-09-23
- HighAvanta administration tube sets may not engage the flow control valve
FDA (Devices) · 2026-06-10
- HighMEDRAD Twist & Go Syringe Recalled Due to Labeling Error
FDA (Devices) · 2021-11-10
- HighBayer Recalls MEDRAD Stellant FLEX Syringe Kits Due to Cracks
FDA (Devices) · 2020-12-02
- HighBayer Medical Care Recalls MAVIG Portegra Overhead Counterpoise Systems
FDA (Devices) · 2019-01-23
Same hazard · contamination
See all →- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighBayer Recalls Medrad Source Administration Sets for Dosing Errors
FDA (Devices) · 2016-01-20
- HighBayer Recalls Medrad Intego PET Infusion System Pumps
FDA (Devices) · 2017-02-15
- HighBayer Medrad Intego PET Infusion Pump Recall for Pressure Testing Failure
FDA (Devices) · 2016-11-23
- HighBayer Recalls Codan Filters Due to Potential Particulate Contamination
FDA (Devices) · 2018-10-17
- HighZyno Medical Administration Set Recalled for Potential Filter Leaking
FDA (Devices) · 2016-10-05
- HighMOOG Curlin Infusion Administration Set Recalled for Filter Leaks
FDA (Devices) · 2019-07-31