Company: B. Braun Medical, Inc.
Date of Enforcement Report:2/122014
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Recall Number Z-0921-2014
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..
B. Braun Medical, Inc. Allantown, PAI 12/13/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
30, 240 units
US Distribution one importer/wholesale distributor in MO