Feb

2014

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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B. Braun AccuFlo Elastomeric Infusion Pump Cl II

Amy Sellers

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