The Recall Desk
HighFDA (Devices)·Z-2553-2021·Announced 2021-10-06

B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery

B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or 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: This is an FDA Class II recall of a medical device with potential risk of serious harm including bloodstream infections and medication delivery failures. No illnesses or injuries have been reported, making this a risk-of-harm classification at the High severity level.

Plain-English summary

B. Braun Medical, Inc. is recalling 1,752 units of the Y-Type Blood Outlook Pump Set (Reference 477005), which is designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids. The recalled lot is identified by Lot Code 0061772234 and Device ID 04046955202799.

The pump sets may leak within the cassette portion, potentially causing delays in medication administration, under-delivery or incomplete dosing of prescribed medications, and possible bloodstream infections.

The affected devices have been distributed worldwide, including throughout the United States and Canada. Healthcare facilities and individuals using these devices should contact B. Braun Medical, Inc. or consult the FDA recall notice for guidance on affected units and recommended actions.

The recalled product

Product
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Infusion Pump Set
Hazard
  • leakage
  • infection-risk
  • under-delivery
  • administration-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: 0061772234 DI: 04046955202799

Distribution

Distributed nationwide across the United States.

Related recalls

Same category