Outlook IV Infusion Pump Set Recalled Due to Backcheck Valve Malfunction Risk
B. Braun is recalling Outlook IV pump sets due to potential backcheck valve malfunction that could allow medication backflow and prevent proper priming, posing a risk of adverse drug reactions and medication loss.
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 medical device with potential for medication delivery compromise through valve malfunction, but no hospitalizations or injuries have been reported. The valve malfunction poses a significant risk of harm through medication backflow and loss, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Outlook OUTLOOK PUMP SET, Model 490361, is an intravenous infusion pump set used with electrically-powered infusion pumps to deliver medications. B. Braun Medical, Inc. is recalling approximately 9,504 units that were distributed nationwide in the US and in Canada.
The backcheck valve in this pump set may malfunction. If this occurs, medication from secondary (piggyback) IV containers could flow backward into primary IV containers, and the pump may be unable to prime correctly. These malfunctions could lead to loss of medication or blood, and may cause adverse drug reactions or other product-related injuries.
B. Braun is recalling all lots of this pump set that were distributed after August 3, 2023. Patients and healthcare providers should contact their medical teams if they have questions about this recall or suspect they may have been affected.
The recalled product
- Product
- Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 9,504
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 (2)
- UDI-DI 04046964642623
- All Lots Distributed After 03AUG2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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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