Bayer Recalls Medrad Intego PET Infusion System Pumps
Bayer is recalling Medrad Intego PET Infusion System pumps because the administration sets may produce particulates in radiopharmaceutical vials.
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: The recall involves a medical device where a defect (particulate production) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bayer Healthcare is recalling the Medrad Intego PET Infusion System - Pump. The device is intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and flushing solutions to patients during molecular imaging diagnostic procedures. It is also intended to provide radiation shielding to medical personnel.
Bayer determined that all current Source Administration Sets (SAS) used with the system may produce particulates in radiopharmaceutical vials when the needle is inserted. The recall covers 178,982 units, with 86,172 units distributed in the United States. The products were distributed nationwide.
Healthcare facilities should stop using the affected devices and contact Bayer for further instructions. Consumers should not use the recalled products.
The recalled product
- Product
- MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective…
- Manufacturer
- Bayer Healthcare
- Category
- Medical Device — Infusion Pump
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)
- Device Listing # D053816
Distribution
Distributed nationwide across the United States.
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