Reported May 8, 2013 · Terminated
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis…
B. Braun Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical, Inc. · 901 Marcon Boulevard · Allentown, PA · 18109-9512
Is this the product you have?
- Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
- Lot codes and dates
- 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.
- Amount recalled
- 1580
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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