B. Braun Recalls Contiplex Tuohy Sets Due to Leakage and Disconnection
B. Braun Medical is recalling 864 Contiplex Tuohy Sets because the catheter connectors 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 and involves a risk-of-harm product (medical device disconnection/leakage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 864 units of the Contiplex Tuohy Set, 18GX6", 1.3X150MM, Material Number 331694. The affected batches are 61610286 and 61619554. These devices were distributed nationwide in the US 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. The product is a connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for the delivery of anesthetics.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected devices and contact B. Braun Medical, Inc. for further instructions.
The recalled product
- Product
- CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 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 conjunctio
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 864
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: 61610286
- 61619554
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.
See all 93 products in this recall →Related recalls
Same manufacturer · B. Braun Medical, Inc.
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22