Recall Z-3384-2018— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2018-07-20, terminated 2020-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 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.. 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-20
- Terminated
- 2020-05-13
- Firm location
- Allentown, PA, United States
Product description
CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.