B. Braun Infusomat SPACE IV Set Backcheck Valve Malfunction Recall
B. Braun Medical is recalling 68,205 Infusomat SPACE IV Sets due to a potential backcheck valve malfunction that could allow medication backflow between IV containers.
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: FDA Class II medical device recall involving IV administration equipment where the backcheck valve malfunction creates potential for medication backflow and adverse drug reactions, although no confirmed injuries are reported in the source text.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat SPACE PUMP IV SET with 2 caresites and ASV (Model/Catalog Number: 363420) due to a potential malfunction in the backcheck valve. The affected units include all lots distributed after August 2, 2023, with UDI-DI 04046964294594.
The backcheck valve in these IV sets may malfunction, allowing medication from secondary (piggyback) IV containers to flow backward into primary IV containers. This backflow can also prevent the IV set from priming properly and may result in loss of medication or blood. Such events could cause adverse drug reactions or other product-related harm.
The recalled products have been distributed nationwide in the United States and in Canada, affecting 68,205 units.
Facilities and providers with this product should discontinue use and contact B. Braun Medical, Inc. for further guidance.
The recalled product
- Product
- Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- medication-backflow
- adverse-drug-reaction
- device-malfunction
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 04046964294594
- All Lots Distributed After 02AUG2023.
Distribution
Distributed nationwide across the United States.
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