Agency classClass IIOur severity:High FDA (Devices)·Z-2558-2021·Announced 2021-10-06

Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery

B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.

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 a Class II recall involving risk-of-harm to patients through potential bloodstream infections and medication under-delivery in infusion systems. No illnesses or injuries have been reported in the source material, placing this at the High severity level per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

B. Braun Medical, Inc. is recalling the Outlook Pump Add-On Set (Reference V7400), a single-use infusion set for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. The recall affects 504 units distributed worldwide, including the United States and Canada, identified by Lot Code 0061765082.

The pump add-on sets may leak within the cassette portion, potentially causing delays in medication administration and incomplete or under-delivery of parenteral fluids. These issues could result in bloodstream infections.

Users of the affected lot should discontinue use immediately and contact B. Braun Medical for replacement sets.

The recalled product

Product: Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Infusion Pump Add-On
Hazard: pump-leakage
under-delivery
bloodstream-infection
medication-delay
Affected units: 504

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: 0061765082 DI: 04046964189258

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 →

Same manufacturer · B. Braun Medical, Inc.

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