B. Braun Outlook IV Pump Sets Recalled Due to Leakage Risk
B. Braun Medical is recalling Outlook pump IV sets used with specific infusion pumps due to leakage in the cassette portion. The defect may prevent proper medication delivery and pose a 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 recall with potential for serious harm including medication delivery failures and bloodstream infection risk; however, no illnesses or injuries have been reported, placing it in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
B. Braun Medical, Inc. is recalling the Outlook Pump IV Set with Universal Spike (Reference 474004), a single-use IV administration set designed for use with the Outlook Safety Infusion System and Horizon NXT Pump. The recall affects 12,216 units distributed nationwide in the United States and Canada.
The recalled pump sets may develop leakage within the cassette portion. This leakage can result in delays in medication administration, under-delivery of prescribed doses, or incomplete dosing. Additionally, the leakage poses a potential risk of bloodstream infections.
Healthcare facilities and patients using these pump sets should discontinue use immediately and contact B. Braun Medical for information on product return and replacement. Patients with questions or concerns about their treatment should speak with their healthcare provider.
The recalled product
- Product
- OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 12,216
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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