Recall Z-2469-2019 ยท OFT Spinal Epidural Anesthesia Kit
B. Braun Medical, Inc.
CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
| Date | Jul 10, 2019 |
| Status | Terminated |
| Reason | The filter capacity is not achieved due to damage of the filter membrane. |
| Root cause | Under Investigation by firm |
| Action | 1. Review the Device Recall Notification entirety and ensure that all users in your organization are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the consumer level. 2. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 3. Utilizing the attached, Product Removal Acknowledgement form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory |
| Quantity | 540 units |
| Distribution | CA FL MO TX MN AL GA NC IL PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.