FDA-Device2014-09-24Class II

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.

B. Braun Medical, Inc.
Hazard

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.

Sold states
Distributed in the state of Missouri.
Affected count
8,640 units
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2655-2014

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