Recall Z-0921-2014— B. Braun Medical, Inc.

Name: FDA recall Z-0921-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-13

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2013-12-13, terminated 2014-09-03. It names one FDA 510(k) clearance: K081905. Product: B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.. Reason: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-13
Terminated: 2014-09-03
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 Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.

Reason for recall

Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

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