B. Braun Medical Recalls Contiplex Tuohy Sets Due to Leakage
B. Braun Medical is recalling 1,848 Contiplex Tuohy Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall, and the source text explicitly reports that leakage and disconnection have been observed, which meets the rubric criteria for a Severe rating.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,848 units of the Contiplex Tuohy Set, 18GX11/2X 1,3X40MM (Material Number 331695). This connection device is 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. The affected batches are 61598006 and 61602664.
The products were distributed nationwide in the United States as well as in Australia, Canada, Guatemala, and Kuwait. The FDA has classified this recall as Class II. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 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…
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,848
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 (2)
- Batch: 61598006
- 61602664
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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