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.
What this means for you
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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