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.
FDA Recall Z-2655-2014 · Posted 2014-09-16
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeMEB
Date Initiated2014-08-06
Date Terminated2015-01-29
Product Quantity8,640 units
Reason for Recall
The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
Firm Action
B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.
Root Cause
Labeling Change Control
Distribution Pattern
Distributed in the state of Missouri.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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