Recall Z-0910-2023 ยท FRN Pump, Infusion
Bayer Medical Care, Inc.
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 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) dia
| Date | Jan 6, 2023 (initiated Nov 30, 2022) |
| Status | Open, Classified |
| Reason | Black specks may be present on the packaged needles |
| Root cause | Under Investigation by firm |
| Action | Bayer US issued Urgent Medical Device Recall (RECALL ID: SA-22-RAD-05 ) Letter on 11/30/22 via email. Letter states reason for recall, health risk and action to take: 1. Review your current inventory for affected Lot 60272154 and quarantine, as appropriate. 2. Complete the included response form and submit through email to ricustomercare@bayer.com or contact our Bayer Customer Service team at 1-800-633-7231, Press 0, then option 3. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all impacted product. 3. |
| Quantity | 2840 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C Medrad, Inc., Jun 23, 2010 |