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U.S. Department of Health and Human Services

Class 2 Device Recall Diacap(R) Ultra Dialysis Fluid Filter

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 Class 2 Recall
Diacap(R) Ultra Dialysis Fluid Filter
see related information
Date Posted April 26, 2013
Recall Status1 Terminated on September 03, 2014
Recall Number Z-1183-2013
Recall Event ID 64504
Premarket Notification
510(K) Number
K052764 
Product Classification System, Dialysate Delivery, Central Multiple Patient - Product Code FKQ
Product Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Code Information Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012. This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113.
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512
For Additional Information Contact Customer Support
800-848-2066
Manufacturer Reason
for Recall
There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action B. Braun Medical Inc. sent and "URGENT RECALL NOTICE" dated February 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Support Department at (800) 848-2066 for questions regarding this issue. This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113. Customers were notified via certified mail on/about June 14, 2013.
Quantity in Commerce 1580
Distribution Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
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 = FKQ and Original Applicant = B. BRAUN MEDIZINTECHNOLOGIE GMBH
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