Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2655-2014

August 06, 2014

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 69054
Status
Terminated
Classification
Class II
Quantity
8,640 units
Official record key
device-enforcement:Z-2655-2014

Official wording

Reason: 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.

Code information: Lot Number: 4A1125F111

Distribution pattern: Distributed in the state of Missouri.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.