IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss
B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.
What this means for you
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: This is an FDA Class II medical device recall involving a malfunction that could result in patient injury through medication backflow and loss. While no specific confirmed illnesses or injuries have been reported, the device directly affects medication delivery to patients and poses a risk of harm.
Plain-English summary
B. Braun Medical, Inc. is recalling OUTLOOK IV SET 15DROP W/3 CARESITE (Model 354213), an intravenous medication administration set used with electrically-powered infusion pumps. The recall is due to a potential malfunction of the backcheck valve in the IV set.
The backcheck valve is designed to prevent medication backflow, but if it malfunctions, medication from secondary (piggyback) containers could flow backward into primary containers. The malfunction may also prevent the IV set from being properly primed before use. These problems could result in loss of medication or blood and potential adverse drug reactions in patients receiving intravenous medication.
The recall affects approximately 88,968 units distributed nationwide in the United States and in Canada. All lots distributed after August 1, 2023 are included in the recall (UDI-DI 04046964182211). Healthcare providers and facilities using the affected IV sets should stop using them immediately and contact B. Braun Medical, Inc. for a replacement.
The recalled product
- Product
- OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- medication-backflow
- medication-loss
- device-malfunction
- adverse-drug-reaction
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 04046964182211
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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