B. Braun Recalls Epidural Trays Due to Catheter Connector Leakage
B. Braun Medical is recalling 1,020 epidural trays because catheter connectors may not stay closed, causing leakage or disconnection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,020 units of the GOVCE17TKFC Epidural Tray with 17GA Tuohy (Material Number 332602). The affected batches are 61604894, 61608062, and 61615893. These devices are connection devices used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids.
The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. This defect could compromise the integrity of the anesthetic delivery system.
The affected products were distributed nationwide in the United States, as well as in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and consumers who have these specific batches should stop using the devices and contact B. Braun Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 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 conjuncti
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch: 61604894
- 61608062
- 61615893
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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