—#116364

Product

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

FDA product code: FKQ — System, Dialysate Delivery, Central Multiple Patient
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K052764
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

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.

Timeline

Recall initiated: 2013-03-01
Posted by FDA: 2013-04-26
Terminated: 2014-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.