Recall Z-0400-2017 ยท FRN Pump, Infusion
Bayer Healthcare
PET Infusion Pump
| Date | Nov 11, 2016 (initiated Sep 30, 2016) |
| Status | Terminated |
| Reason | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date. |
| Root cause | Process control |
| Action | Bayer mailed an Urgent Medical Device Customer Notification letter to the affected consignees on September 30, 2016 asking that they review their current SAS inventory and determine if you have any product that is more than one year past its manufacturing date, Quarantine unused units and call Bayer Customer Care line to receive a Return Goods Authorization (RGA) number for the product's return. |
| Quantity | 165,127 (79,714 units in U.S.) |
| Distribution | Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Ki |
| FDA record | Open on fda.gov |