Recall Z-0483-2021 ยท DXT Injector And Syringe, Angiographic
Bayer Medical Care, Inc.
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.
| Date | Oct 5, 2020 |
| Status | Terminated |
| Reason | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. |
| Root cause | Process control |
| Action | On 10/08/020, Bayer sent all of their affected customers an Urgent Medical Device Field Corrective Action (recall) letter via e-mail. The recall letter requested that all of the affected customers immediately take the following steps: 1. Review your current inventory. Quarantine any affected batch/lot numbers referenced in the below chart. Instructions are included in this letter on how to identify batch/lot. 2. Complete the included response form and submit through email to CLSCRiCustomerLogistics@bayer.com or contact the Customer Logistics team at 724-940-7890. Please complete the Customer |
| Quantity | 92,420 units |
| Distribution | Distributed to healthcare facilities nationwide throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation Bayer Medical Care, Inc., Dec 13, 2019 |