Reported Jan 18, 2023 · Ongoing
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS…
Bayer Medical Care, Inc.
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 Medical Care, Inc. · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Source Administration Set (SAS) used with the Medrad Intego PET Infusion System
- Sterile Catalog numberINT
- CSS Affected material number86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures
- Lot codes and dates
- UDI(01)00616258021478(11)201209(17)231209(10)60272154
- Batch number60272154
- Expiration date
December 92023
- Amount recalled
- 2840 units
Where it was sold
Why it was recalled
Black specks may be present on the packaged needles
This product could cause temporary or reversible health problems — stop using it.
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