Recall Z-0627-2016 ยท FRN Pump, Infusion
Bayer Healthcare
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
| Date | Jan 11, 2016 (initiated Nov 30, 2015) |
| Status | Terminated |
| Reason | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail |
| Root cause | Nonconforming Material/Component |
| Action | Bayer Healthcare sent an "Urgent Medical Device Field Corrective Action" letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately take the following steps. Please review your current inventory. Do not use any Source Administration Sets (SAS) with the impacted batch numbers that are included in the index below. If you have unused affected product, immediately quarantine the product and please call Bayer Customer Service at 1-800-633-7231 to receive a Returned Goods Authorizati |
| Quantity | 198,598 |
| Distribution | Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI. |
| 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 |