B. Braun Medical Recalls Contiplex Echo OT Catheter Connectors
B. Braun Medical is recalling 190 units of Contiplex Echo OT catheter connectors because they may not stay closed, causing 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 is classified as FDA Class II and involves a risk-of-harm product (leakage/disconnection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling 190 units of the CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762. This 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.
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 catheter connectors has been observed. The affected units are identified by Batch 61598015.
The product was distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. The FDA has classified this recall as Class II, which means use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 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
- 190
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: 61598015
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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