B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays
B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.
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: FDA Class II medical device recall involving serious potential hazards—medication delivery delays, under-dosing, and bloodstream infection risk—but no illnesses or injuries reported. Per the rubric, risk-of-harm products where injury has not yet been reported merit High (3) severity.
Plain-English summary
B. Braun Medical, Inc. is recalling 768 units of the Outlook Pump Set 3 Caresite LADS 133 in. (Reference 490564), a single-use infusion pump set designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. The recalled product was distributed worldwide, including the United States and Canada.
The pump sets may leak within the cassette portion of the device. This leakage could delay the administration of medications or result in under-delivery or incomplete dosing of prescribed medications. Potential complications include bloodstream infections.
Patients and healthcare facilities using the recalled pump sets should stop using them immediately and contact B. Braun Medical or their healthcare provider. If you have used this product and have concerns about your health, consult your healthcare provider.
The recalled product
- Product
- OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 768
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: 0061769182 DI: 04046955275588
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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