IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration
B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking 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 recall involving a serious hazard—backflow of medication and priming failure during IV administration—that could result in adverse drug reactions and medication loss. Per the rubric, this qualifies as a risk-of-harm medical device, and no confirmed injuries or hospitalizations are reported in the source.
Plain-English summary
The OUTLOOK PUMP SET 3 CARESITE LADS 133 IN. (Model 490564), manufactured by B. Braun Medical, Inc., is an intravenous (IV) infusion set used with electrically-powered infusion pumps to administer medication intravenously. The company is recalling 2,352 units distributed nationwide throughout the US and in Canada.
The backcheck valve in the pump set may malfunction, allowing medication to flow backward from secondary (piggyback) IV containers into primary IV containers. This malfunction can also prevent the system from priming properly. These failures can result in adverse drug reactions and loss of medication or blood.
Healthcare providers using affected units should stop use immediately and contact B. Braun Medical for guidance on affected lots and return procedures. All lots distributed after August 22, 2023 are included in this recall (UDI-DI 04046955275588).
The recalled product
- Product
- OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 2,352
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 04046955275588
- All Lots Distributed After 22AUG2023.
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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