B. Braun AccuFlo Elastomeric Infusion Pump Cl II

Company: B. Braun Medical, Inc.
Date of Enforcement Report:2/122014
Class lI:

PRODUCT

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

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/MANUFACTURER
B. Braun Medical, Inc. Allantown, PAI 12/13/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
30, 240 units

DISTRIBUTION
US Distribution one importer/wholesale distributor in MO

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.