Recall Z-1183-2013— B. Braun Medical, Inc.

Name: FDA recall Z-1183-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-01

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2013-03-01, terminated 2014-09-03. It names one FDA 510(k) clearance: K052764. Product: Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.. Reason: 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)..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-01
Terminated: 2014-09-03
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K052764 — DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbH·cleared 2006-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.