Recall Z-2655-2014— B. Braun Medical, Inc.

Name: FDA recall Z-2655-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-06

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2014-08-06, terminated 2015-01-29. It names one FDA 510(k) clearance: K081905. 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.. 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Terminated: 2015-01-29
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPWestmed, Inc.·cleared 2008-07-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.