Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction
B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to adverse drug reactions.
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: This is a risk-of-harm medical device where the source text does not explicitly report injuries or hospitalizations. The malfunction involves high-risk intravenous medication administration with potential for serious adverse drug reactions or medication loss, meeting the criterion for High severity.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV (Model/Catalog Number 363430), an electrically-powered infusion pump set used for intravenous (IV) administration of medications.
The backcheck valve in these infusion pump sets may malfunction, potentially causing medication from secondary IV containers to backflow into primary IV containers. This malfunction may also prevent the infusion set from being primed properly. These conditions could result in loss of medication or blood, or patients receiving unintended drug reactions due to medication mixing or incorrect administration.
The recall affects all lots distributed after August 1, 2023, distributed worldwide including the United States and Canada. Approximately 2,085,606 units are affected.
Healthcare providers and patients using affected Infusomat UNIV. 15 infusion pump sets should discontinue use immediately and contact B. Braun Medical, Inc. for replacement or return instructions.
The recalled product
- Product
- Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 2,085,606
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 04046964294679
- 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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