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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device

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  Class 2 Device Recall B. Braun AccuFio 100ML/H 100ML Elastomeric Infusion Device see related information
Date Initiated by Firm August 06, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on January 29, 2015
Recall Number Z-2655-2014
Recall Event ID 69054
510(K)Number K081905  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device.

AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
Code Information Lot Number: 4A1125F111
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Customer Support
610-596-2870
Manufacturer Reason
for Recall		 The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
FDA Determined
Cause 2		 Labeling Change Control
Action B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.
Quantity in Commerce 8,640 units
Distribution Distributed in the state of Missouri.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = Westmed, Inc.
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