The Recall Desk
HighFDA (Devices)·Z-2556-2021·Announced 2021-10-06

Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk

B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially 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 involving infusion equipment with potential for serious medication delivery failures and bloodstream infections. No reported illnesses or injuries are mentioned in the source, so per the rubric this scores as High (3) rather than Severe (4).

Plain-English summary

B. Braun Medical, Inc. is recalling 7,248 units of the Outlook Pump Set (Ref: 490361), a single-use infusion pump set designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for administering parenteral fluids. The recalled units are identified by lot codes 0061757775, 0061765083, and 0061777822.

The pump sets may leak within the cassette portion, which could result in delays in medication administration, under-delivery of medications, or incomplete dosing. These failures create potential risks including bloodstream infections due to incomplete or delayed delivery of critical intravenous fluids.

The affected product was distributed nationwide in the United States and in Canada.

The recalled product

Product
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Infusion Equipment
Hazard
  • device-leakage
  • under-delivery
  • bloodstream-infection
  • medication-delay

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: 0061757775 0061765083 0061777822 DI: 04046964642623

Distribution

Distributed nationwide across the United States.

Related recalls

Same category