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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun

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 Class 2 Recall
B. Braun
see related information
Date Posted February 03, 2014
Recall Status1 Terminated on September 03, 2014
Recall Number Z-0921-2014
Recall Event ID 67172
Premarket Notification
510(K) Number
K081905 
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Code Information Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Blvd
Allentown, Pennsylvania 18109-9512
For Additional Information Contact Customer Support
610-596-2870
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action B. Braun Medical sent an Urgent Medical Device Recall letter dated December 13, 2013 to affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter was sent to Progressive Medical Inc., the Importer and B. Braun's sole customer. WHAT ACTIONS SHOULD I TAKE? 1. Further use and/or distribution of the affected product should be discontinued immediately. Please identify and quarantine any impacted materials in your possession. 2. Review this recall notification in its entirety and ensure that all users within your organization and any consignees your organization may have are informed of this recall. If you are a distributor, please forward this recall notice to any customers who are in receipt of the impacted product. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Recall Acknowledgement" form record the number of full cases and individual units (for any loose units or partial cases) in your possession. If you have no inventory, please indicate that you have zero (0) inventory on the "Recall Acknowledgement" form. 5. Return the completed "Recall Acknowledgement" form to B. Braun Medical Inc. Quality Assurance who will administer the recall on behalf of B. Braun Melsungen AG. The form must be e-mailed to PA_QualityAssurance.BBMUS.Service@bbraun.com or faxed to (610) 849-1197 within two (2) weeks of receipt even it the inventory in your possession is zero. 6. Instructions for Credit, Replacement, Et Return: a.If you have purchased the product from a third-party and have any full cases, partial cases, or unused individual pieces in your possession please contact the seller to obtain instructions for handling these units. b.If you have purchased the product directly from B. Braun Medical Inc. and have any full cases, partial cases, or unused individual pieces of these affected products, ple.
Quantity in Commerce 30, 240 units
Distribution US Distribution one importer/wholesale distributor in MO.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = Westmed, Inc.
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