PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 24, 2014 Initiated: August 6, 2014 #Z-2655-2014

Product Description

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.

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
8,640 units
Distribution
Distributed in the state of Missouri.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by B. Braun Medical, Inc.. Units affected: 8,640 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 24, 2014. Severity: Moderate. Recall number: Z-2655-2014.