Reported Feb 15, 2017 · Terminated
MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride…
Bayer Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Healthcare · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- 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.
- Lot codes and dates
- Device Listing # D053816
- Amount recalled
- 178,982 (86,172 units in U.S.)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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