B. Braun Medical Recalls 18GA Tuohy Catheter Connectors for Leakage
B. Braun Medical is recalling 18GA Tuohy catheter connectors because they may not stay closed, leading to 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 is classified as FDA Class II. The hazard involves a functional defect in a medical device used for anesthetic delivery, which poses a risk of harm (leakage/disconnection) but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
B. Braun Medical, Inc. is recalling the CE18TKCD10L 18GA Tuohy/10CC GLAS catheter connectors, Material Number 332217. These connection devices are used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids. The recall involves 11,130 units distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.
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 poses a risk of fluid leakage or loss of connection during medical procedures.
Healthcare providers and facilities should stop using the affected connectors. Consumers and patients should contact their healthcare provider if they have received or used these specific devices. The affected batch numbers are 61592523, 61599135, 61616706, and 61616705.
The recalled product
- Product
- CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 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
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 11,130
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 (4)
- Batch: 61592523
- 61599135
- 61616706
- 61616705
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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