Recall Z-0927-2017 ยท FRN Pump, Infusion
Bayer Healthcare
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.
| Date | Nov 7, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, |
| Quantity | 178,982 (86,172 units in U.S.) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.