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Terminated

Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.

FDA Recall Z-1183-2013 · Posted 2013-04-26

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFKQ
Date Initiated2013-03-01
Date Terminated2014-09-03
Product Quantity1580

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).

Firm 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.

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbH · 2006-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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