Recall Z-3387-2018 ยท BSO Catheter, Conduction, Anesthetic
B. Braun Medical, Inc.
GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
| Date | Jul 20, 2018 |
| Status | Terminated |
| Reason | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. |
| Root cause | Under Investigation by firm |
| Action | The firm, B. Braun, sent an "URGENT MEDICAL DEVICE CORRECTION RECALL NOTIFICATION" letters dated 7/20/18 to its customers. The letters described the product, problem and actions to be taken. The letters instruct customers to do the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the mentioned products in your organization and other concerned persons are informed about this Medical Device Correction Recall Notification. If you are a distributor, please forward this recall notification to your customers. 2. For continued safe use |
| Quantity | 1030 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.