Devices

Device Recall Diacap(R) Ultra Dialysis Fluid Filter

Model / Serial
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.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
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 Description
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. || Intended to filter bacteria and endotoxins from dialysis fluid.
Manufacturer
B. Braun Medical, Inc.
1 Event
- Recall of Device Recall Diacap(R) Ultra Dialysis Fluid Filter

Manufacturer

B. Braun Medical, Inc.

Manufacturer Address
B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA

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