Recall Z-1183-2013 ยท FKQ System, Dialysate Delivery, Central Multiple Patient
B. Braun Medical, Inc.
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
| Date | Apr 26, 2013 (initiated Mar 1, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER B. Braun Medizintechnologie GmbH, Jun 9, 2006 |