Diacap(R) Ultra Dialysis Fluid Filter recall
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Why was Diacap(R) Ultra Dialysis Fluid Filter 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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
- Recalling firm
- B. Braun Medical, Inc.
- 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.
- Recall date
- May 8, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)