Agency classClass IIOur severity:High FDA (Devices)·Z-2551-2021·Announced 2021-10-06

Outlook V1500HP Pump Set Recalled for Cassette Leakage

The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.

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 recall for a documented pump cassette defect creating risk of medication underdosing and bloodstream infection—both serious complications. No reported illnesses or hospitalizations are documented in the source, placing it at High severity rather than Severe.

Plain-English summary

The Outlook V1500HP Pump Set 118, manufactured by B. Braun Medical, Inc., is being recalled. The pump set is designed for single-use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids.

A defect in the pump cassette can cause leakage. This leakage may delay medication administration, cause under-delivery or incomplete dosing of medications, and create the potential for bloodstream infections.

The recall affects 12,000 units with worldwide distribution, including US nationwide and Canada. The affected lot codes are 0061756809, 0061763935, 0061768485, and 0061777803 (DI: 04046964297434).

If you have or are using these pump sets, contact your healthcare provider or B. Braun Medical, Inc. immediately. Do not use the affected units.

The recalled product

Product: V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Infusion / IV Administration
Hazard: pump-leakage
incomplete-dosing
bloodstream-infection
Affected units: 12,000

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)

Lot Code: 0061756809 0061763935 0061768485 0061777803 DI: 04046964297434

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

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