Diacap — Class II medical device recall Z-1183-2013
Terminated recall by B. Braun Medical, Inc., reported 2013-05-08, distributed nationwide. There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which re
| Recall number | Z-1183-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2013-03-01 |
| Classified | 2013-04-26 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,580 |
| Lot numbers | 302950410, 305000113, 305010113, 305880812, 306301012, 306311012, 309910111, 313050411, 314300511, 316040711, 316450711 |
| Model numbers | 7107367 |
Product
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1183-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.