CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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.
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Enforcement
- Recall Number
- Z-3331-2018
- Event ID
- 80811
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- B. Braun Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 10, 2018
- Initiation Date
- July 20, 2018
- Classification Date
- October 1, 2018
- Termination Date
- May 13, 2020
- Address
- 901 Marcon Blvd, Allentown, PA, 18109-9512, United States
Description
CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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.
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.
Batch: 61595534, 61596125, 61601680, 61604904, 61607912, 61607913, 61607914, 61607915, 61607911, 61607916, 61607917, 61607918, 61607921, 61609180, 61610345, 61607922, 61607919, 61607920
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
60760