Agency classClass IIOur severity:Severe FDA (Devices)·Z-3375-2018·Announced 2018-10-10

B. Braun Medical Recalls Epidural Catheter Connectors Due to Leakage

B. Braun Medical is recalling 1,980 epidural catheter connectors because they 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 source identifies this as a Class II recall involving a medical device used for anesthetic delivery where leakage or disconnection has been observed, fitting the 'Severe' criteria for significant injury risk or structural defect.

Plain-English summary

B. Braun Medical, Inc. is recalling 1,980 units of the CE17TB19C CONT EPIDURAL TRAY (Material Number 332242). These connection devices are used by physicians to provide a single 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 61620798 and 61583520.

The product was distributed nationwide in the United States, as well as in Australia, Canada, Guatemala, and Kuwait. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 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.
Category: Medical Device — Catheter Connectors
Hazard: leakage
disconnection
Affected units: 1,980

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: 61620798
61583520

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 →

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Same hazard · leakage