Blood Administration Pump Set Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook Pump Blood Administration Sets due to leakage in the pump cassette that could delay or prevent complete medication delivery and increase infection risk.
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 device recall with no reported adverse events or hospitalizations. The defect creates genuine risk of incomplete medication delivery and bloodstream infection, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling the Outlook Pump Blood Administration Set with SAFELINE Injection Site (Ref: NF3120) due to leakage in the pump cassette portion. The leakage can result in delays in medication administration, under-delivery or incomplete dosing of prescribed medications, and potential for bloodstream infections.
The affected product consists of 336 units with Lot Code 0061769045 (DI: 04046964187322) that were distributed in the United States and Canada.
Healthcare facilities and clinicians currently using affected units should immediately discontinue use and contact B. Braun Medical for replacement instructions. Patients who received treatment with affected units should consult their healthcare provider if they experience any symptoms of infection or concerns about the completeness of their medication dosing.
The recalled product
- Product
- Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: NF3120
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device
- Affected units
- 336
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: 0061769045 DI: 04046964187322
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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