Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk
B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or 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 an FDA Class II recall involving a risk-of-harm medical device with potential serious complications (bloodstream infections). The source indicates potential risks without reported illnesses or injuries, placing it at Score 3 (High) per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Outlook Pump IV Set (catalog reference 477009), a single-use infusion set for use with the Outlook Safety Infusion System and Horizon NXT Pump. This recall affects 504 units with Lot Code 0061783984.
The pump set may leak within the cassette portion, potentially causing delays in medication administration, under-delivery or incomplete dosing of medications, and bloodstream infections.
The affected product was distributed worldwide, including throughout the United States and Canada. Healthcare facilities and patients using this product should discontinue use and contact B. Braun Medical or their healthcare provider for instructions on replacement or alternative equipment.
The recalled product
- Product
- OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
- Manufacturer
- B. Braun Medical, Inc.
- 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: 0061783984 DI: 04046955202935
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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