B. Braun Medical Recalls CONTIPLEX CONT 4 IN TUOHY ULTRA PNB Trays
B. Braun Medical is recalling 340 units of CONTIPLEX CONT 4 IN TUOHY ULTRA PNB trays 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 3/5 (High).
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 without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 340 units of the CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129. This connection device is used by physicians to provide a single access point to a catheter for the delivery of anesthetics and fluids. The affected units are identified by Batch 61602900.
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 delivery of anesthetic fluids.
The affected products were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and users should stop using the affected trays and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 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
- 340
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 (1)
- Batch: 61602900
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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