Agency classClass IIOur severity:High FDA (Devices)·Z-2546-2021·Announced 2021-10-06

Outlook Pump IV Sets Recalled for Leakage and Infection Risk

B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.

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 FDA medical device recall involving a high-risk IV infusion product. The hazard involves leakage that could delay critical medication delivery and increase infection risk. No illnesses or injuries have been reported, making this a risk-of-harm scenario with theoretical potential for serious consequences.

Plain-English summary

B. Braun Medical, Inc. is recalling the Outlook® Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE® Y-Sites (Reference 354214). This single-use intravenous infusion set is designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for delivery of parenteral fluids. Approximately 44,866 units have been distributed nationwide in the United States and in Canada.

The recall was issued due to leakage of the pump set within the cassette portion of the product. This defect can result in delays in medication administration, under-delivery or incomplete dosing of medications, and potential for bloodstream infections.

Healthcare facilities and patients using these IV sets should be aware of this recall. Affected units are identified by the following lot codes: 0061752471, 0061756801, 0061757861, 0061766196, and 0061777798. The Device Identifier (DI) is 04046964182235. Healthcare providers should contact B. Braun Medical, Inc. or the FDA for guidance.

The recalled product

Product: Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — IV Infusion Set
Hazard: leakage
bloodstream-infection
under-delivery
Affected units: 44,866

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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Same hazard · leakage