MEDRAD Intego PET Infusion System — Class II medical device recall Z-0927-2017
Terminated recall by Bayer Healthcare, reported 2017-02-15, distributed nationwide. Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusio
| Recall number | Z-0927-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2017-02-07 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-10-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
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 radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
Reason for recall
Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.