B. Braun AccuFlo Elastomeric Infusion Device Labeling Recall
B. Braun Medical is recalling AccuFlo infusion devices in Missouri due to a mismatch between inner and outer packaging labels.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling mismatch without reporting any illnesses, injuries, or specific clinical harm, fitting the criteria for moderate severity.
Plain-English summary
B. Braun Medical, Inc. is recalling 8,640 units of B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Devices. The recall is limited to Lot Number 4A1125F111, which was distributed in the state of Missouri.
The recall was initiated because of a labeling discrepancy. The primary packaging label (inner pouch) indicates the contents are Catalog Item CT-1000-250, while the secondary packaging label (outer carton) indicates the contents are CT-1000-100. The actual contents of the package are CT-1000-100.
These devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites, or epidural administration of medications. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.
The recalled product
- Product
- B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 8,640
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 (1)
- Lot Number: 4A1125F111
Distribution
Distributed in 1 state:
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