IV Infusion Pump Set Backcheck Valve Malfunction Recall
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in 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: FDA Class II medical device with a documented malfunction mechanism that poses a risk of patient harm through medication loss and adverse drug reactions. However, no reported illnesses, hospitalizations, or deaths are documented in the recall notice.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV (Model 363433), a pump set component used with electrically-powered infusion pumps for intravenous (IV) medication administration. A total of 42,028 units have been recalled worldwide, including US Nationwide and Canada. The recalled units were distributed after August 3, 2023, and can be identified by UDI-DI 04046964837920.
The backcheck valve in these pump sets can malfunction, causing medication to flow backward from secondary (piggyback) IV containers into primary IV containers. This malfunction can also prevent the pump from priming properly, resulting in loss of medication or blood and potential adverse drug reactions in patients.
Healthcare providers and patients should immediately discontinue use of affected units and contact B. Braun Medical, Inc. for instructions on replacement or return. Patients who have received IV medications through these pump sets and experience symptoms or concerns should consult their healthcare provider.
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: 363433
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 42,028
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 04046964837920
- 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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