Agency classClass IIOur severity:High FDA (Devices)·Z-3404-2018·Announced 2018-10-10

B. Braun Recalls Pain Management Trays Due to Catheter Leakage

B. Braun Medical is recalling Design Options Pain Management Trays because 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 is classified as FDA Class II, and the hazard involves a risk of harm (leakage/disconnection of medical devices) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

B. Braun Medical, Inc. is recalling Design Options Pain Management Trays, identified by specific material numbers and batch codes, due to a defect in the catheter connectors. The connectors may not stay closed during use, which has resulted in observed leakage or disconnection of the catheters from the connectors.

These trays are used by physicians to provide anesthetics and fluids through a single access point to a catheter. The recall affects approximately 296,400 units that were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.

Healthcare facilities should stop using the affected trays and contact B. Braun Medical for instructions on how to return or replace the devices.

The recalled product

Product: DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 530112, 530122, 530123, 530124, 530132, 530133, 530134, 530138, 530141, 530142, 530149, 530153, 530155, 530159, 530160, 530164, 530168, 530169…
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Anesthesia / Pain Management
Hazard: leakage
disconnection
Affected units: 296,400

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 (6)

Batch: 61591833
61599662
61602691
61607729
61616956
61585954

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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