Outlook pump extension sets recalled due to leakage and dosing errors
Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.
What this means for you
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 recall for a medical device with risk of serious medication delivery failure and potential bloodstream infections. The source reports no actual illnesses or injuries, making this a risk-of-harm scenario where injury has not yet been reported, warranting a High severity score per the rubric.
Plain-English summary
B. Braun Medical, Inc. is recalling the ET82HP Outlook pump extension set (Lot Code 0061770206), a single-use infusion set designed for use with Outlook Safety Infusion Systems and/or Horizon NXT Pumps for parenteral fluid administration.
The recalled sets may experience leakage within the cassette portion. This leakage can result in delays in medication administration, under-delivery, incomplete dosing, and potential bloodstream infections.
The product was distributed worldwide, including nationwide throughout the United States and Canada. A total of 200 units were distributed under this recall.
Patients and healthcare providers using this product should discontinue use immediately. Contact the manufacturer or the FDA for replacement and proper handling instructions. Healthcare facilities should review patient records for anyone who may have received medications through affected sets and monitor for any signs of infection or complications related to incomplete medication delivery.
The recalled product
- Product
- ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- leakage
- dosing-error
- bloodstream-infection
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: 0061770206 DI: 04046964297410
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03