IV infusion set recalled due to backcheck valve malfunction
B. Braun is recalling OUTLOOK IV sets due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers and prevent proper priming, potentially resulting in patient injury.
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 involving risk of patient harm from improper medication delivery through valve malfunction and backflow. No reported injuries are stated in the source; the severity reflects the potential for adverse drug reactions and medication loss rather than confirmed incidents.
Plain-English summary
B. Braun Medical, Inc. is recalling OUTLOOK IV SET 15DROP W/2 CARESITE (Model 354212), an intravenous infusion set designed for use with electrically-powered infusion pumps. Approximately 236,208 units with UDI-DI 04046964293832 that were distributed after August 1, 2023, are affected by this recall. Distribution includes the United States nationwide and Canada.
The backcheck valve in these IV sets may malfunction, potentially allowing medication from secondary (piggyback) IV containers to flow backward into primary IV containers. The malfunction could also prevent the IV set from being properly primed before use.
If the valve malfunctions, patients may experience loss of medication, improper drug administration, or adverse reactions related to the backflow. Patients and healthcare facilities using these IV sets should stop using affected units and consult with their healthcare provider. Contact B. Braun Medical, Inc. for information about replacement products or return procedures.
The recalled product
- Product
- OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 236,208
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)
- UDI-DI 04046964293832. All Lots Distributed After 01AUG2023.
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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