What is recalled and which product is affected?

The Outlook IV Set 15DR W/2 CARESITE FILTER, Catalog 354214, is recalled due to backflow risk and occlusion potential when used with BBMI pumps.

What is the hazard and how might it affect patients?

Backflow from secondary piggyback IV containers into primary containers can lead to unintended dosing or contamination. An occlusion can prevent priming and flow.

Are there any injuries reported?

No injuries or incidents have been reported in connection with this recall.

Who should stop using the device?

Hospitals and clinicians using the Outlook IV Set 15DR W/2 CARESITE FILTER with BBMI pumps should stop using it immediately.

How will I know if my device is affected?

Check the Catalog Number 354214 and verify Primary UDI-DI 04046964182235 and Unit of Dose UDI-DI 04046964182228 on labeling.

What should I do next?

Stop using the device and await recall instructions from the manufacturer. Contact B. Braun Medical Inc for guidance.

How can I contact the manufacturer?

The recall page lists the manufacturer as B. Braun Medical; use the FDA recall page for contact details and instructions.

Where can I find the official recall notice?

The official notice is available on the FDA enforcement page for Z-0716-2026.

Will I receive a refund or replacement?

Remedy details specify stopping use and following recall instructions. Check with the manufacturer for replacement options.

What pumps are involved with this recall?

Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump are mentioned in the recall.

What is the catalog number and model name?

Catalog Number 354214; Outlook IV Set 15DR W/2 CARESITE FILTER.

What documentation should I keep?

Keep recall letters and any correspondences; photograph device labeling and catalog/UDI numbers for records.

HIGHOctober 29, 2025

B. Braun Medical Outlook IV Set 354214 Recalled for Backflow Risk (2025)

B. Braun Medical recalled the Outlook IV Set 15DR W/2 CARESITE FILTER (Catalog 354214) used with Infusomat Space pumps and BBMI devices. The recall cites backflow from secondary piggyback IV containers into primary containers and an inability to prime. Hospitals and healthcare providers should stop using the device immediately and follow recall instructions by mail.

Quick Facts at a Glance

Recall Date: October 29, 2025
Hazard Level: HIGH
Brand: B. Braun Medical
Category: Health & Personal Care
Sold At: Multiple Retailers
At-Risk Groups: GENERAL

Hazard Information

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Outlook IV Set is used in gravity IV administration and pump-driven IV administration with BBMI pumps such as Infusomat Space, Outlook Pump, and Vista Basic Pump.

Why This Is Dangerous

A backflow risk exists when medication from secondary containers can re-enter the primary IV line. The device may be unable to prime, potentially interrupting therapy.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may need to halt use, replace affected sets, and review IV therapy workflows to avoid delays in treatment.

Practical Guidance

How to identify if yours is affected

Check labeling for Catalog Number 354214 and model Outlook IV Set 15DR W/2 CARESITE FILTER.
Verify Primary UDI-DI 04046964182235 and Unit of Dose UDI-DI 04046964182228.
Confirm compatibility with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

Where to find product info

FDA recall page, manufacturer recall communications, and labeling on the device.

What timeline to expect

Recall processing timelines are not specified; expect notification by letter and replacement instructions to follow.

If the manufacturer is unresponsive

Document all attempts to contact the manufacturer
If necessary, escalate to hospital procurement or file a consumer complaint with authorities

How to prevent similar issues

Implement backflow-prevention checks in IV sets procurement
Verify device compatibility with BBMI pumps before purchase
Review suppliers' recall compliance processes

Documentation advice

Keep recall notices, purchase records, and correspondence; photograph product labeling and UDI codes for records

Product Details

Catalog Number: 354214; Model: Outlook IV Set 15DR W/2 CARESITE FILTER; Primary UDI-DI: 04046964182235; Unit of Dose UDI-DI: 04046964182228; Distribution: Worldwide (US distribution and international distribution to Canada, Germany, Guatemala, and Singapore). Expiration: Earliest Exp of Component or 36 months.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Catalog Number: 354214
Model: Outlook IV Set 15DR W/2 CARESITE FILTER
Primary UDI-DI: 04046964182235
Unit of Dose UDI-DI: 04046964182228
Distribution: Worldwide (US and international incl. Canada, Germany, Guatemala, Singapore)
Expiration: Earliest Exp of Component or 36 months

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeIV administration set

Product Details

Brand

B. Braun Medical

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