Z-1183-2013Class II

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

Name: Z-1183-2013 Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins...
Creator: B. Braun Medical, Inc.
Published: 2013-03-01
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2013-03-01 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid on 2013-03-01. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1183-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-01
Posted: 2013-04-26
Terminated: 2014-09-03
Recalling firm: B Braun Medical Inc
Product: Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Product code: FKQ System, Dialysate Delivery, Central Multiple Patient
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).
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1183-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1183-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-26

Product code FKQ

K052764Class IIDiacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH / cleared 2006-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)