The Recall Desk
HighFDA (Devices)·Z-1183-2013·Announced 2013-05-08

B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss

B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential reduction in membrane permeability which could affect the device's ability to filter bacteria and endotoxins, representing a risk of harm where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 1,580 units of the Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. The product is intended to filter bacteria and endotoxins from dialysis fluid. The recall was expanded on or about June 18, 2013, to include additional lot numbers.

The recall is being conducted because there is a potential for the residual moisture of the Diacap Ultra membrane to be reduced over time. This reduction in moisture results in a reduction of the membrane permeability, also known as the ultrafiltration coefficient. The affected lots were distributed nationwide, including in 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. Distribution dates for the expansion lots were reported as May 23 to June 14, 2013, and manufacturing dates as January 22 to 24, 2013.

The affected lot numbers are 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, 306311012, 305010113, and 305000113. Healthcare facilities and consumers should stop using the affected filters and contact B. Braun Medical, Inc. for instructions on return or replacement.

The recalled product

Product
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Dialysis Filter
Hazard
Affected units
1,580

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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