Bayer Medrad Intego PET Infusion Pump Recall for Pressure Testing Failure
Bayer Healthcare is recalling PET Infusion Pumps used with the Medrad Intego system because they may fail pressure testing specifications when more than one year past the manufacturing date.
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 is classified as FDA Class II, and the hazard involves a medical device failing pressure testing specifications, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Bayer Healthcare is recalling PET Infusion Pumps used with the Medrad Intego PET Infusion System. The recall involves 165,127 units globally, with 79,714 units distributed in the United States. The products were distributed nationwide and internationally to numerous countries including Taiwan, Ukraine, Turkey, and the United Kingdom.
The recall is due to a defect where the Source Administration Sets (SAS) used with the system do not meet pressure testing specifications in an occlusion situation when the product is more than one year past its manufacturing date. This failure could potentially affect the safety of the infusion process.
Healthcare facilities and users should check their inventory for the specific batch numbers listed in the recall notice. If the product is more than one year past the manufacturing date, it should be removed from service and returned to Bayer Healthcare according to their instructions.
The recalled product
- Product
- PET Infusion Pump
- Manufacturer
- Bayer Healthcare
- Category
- Medical Device — Infusion Pump
Distribution
Distributed nationwide across the United States.
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Similar recalls
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