Agency classClass IIOur severity:High FDA (Devices)·Z-2377-2024·Announced 2024-07-24

IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss

B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.

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: This is an FDA Class II medical device recall involving a malfunction that could result in patient injury through medication backflow and loss. While no specific confirmed illnesses or injuries have been reported, the device directly affects medication delivery to patients and poses a risk of harm.

Plain-English summary

B. Braun Medical, Inc. is recalling OUTLOOK IV SET 15DROP W/3 CARESITE (Model 354213), an intravenous medication administration set used with electrically-powered infusion pumps. The recall is due to a potential malfunction of the backcheck valve in the IV set.

The backcheck valve is designed to prevent medication backflow, but if it malfunctions, medication from secondary (piggyback) containers could flow backward into primary containers. The malfunction may also prevent the IV set from being properly primed before use. These problems could result in loss of medication or blood and potential adverse drug reactions in patients receiving intravenous medication.

The recall affects approximately 88,968 units distributed nationwide in the United States and in Canada. All lots distributed after August 1, 2023 are included in the recall (UDI-DI 04046964182211). Healthcare providers and facilities using the affected IV sets should stop using them immediately and contact B. Braun Medical, Inc. for a replacement.

The recalled product

Product: OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Infusion Set
Hazard: medication-backflow
medication-loss
device-malfunction
adverse-drug-reaction
Affected units: 88,968

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)

UDI-DI 04046964182211
All Lots Distributed After 01AUG2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 29 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 29 products in this recall →

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