Outlook Pump Measured Volume Solution Set recalled for cassette leakage
B. Braun is recalling 940 units of Outlook Pump Measured Volume Solution Sets due to potential leakage in the cassette. The leakage could delay medication delivery, result in incomplete dosing, or lead to 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 medical device with potential for serious consequences including medication delivery delay, under-delivery, and bloodstream infection. However, the source does not report any actual illnesses, injuries, or deaths. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
B. Braun Medical, Inc. is recalling 940 units of the Outlook Pump Measured Volume Solution Set with Auto Shut-Off (reference 375118). This is a single-use medical device designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump to deliver parenteral fluids intravenously.
The device may experience leakage within the cassette portion of the pump set. This leakage could delay the delivery of medications to patients, result in under-delivery or incomplete dosing of prescribed medications, and potentially lead to bloodstream infections.
The recalled devices were distributed worldwide, including throughout the United States and Canada. The affected lot code is 0061757772 (Device Identifier: 04046964182877).
The recalled product
- Product
- Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 375118
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion System
- Affected units
- 940
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: 0061757772 DI: 04046964182877
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.
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