FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
- Recall number
- Z-1183-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-03-01
- Posted
- 2013-04-26
- Terminated
- 2014-09-03
- 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).
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K052764
- PMA numbers
- not on file
- Product code
- FKQ
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28