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NxStage Medical, Inc. recalls NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030,
Recalled March 7, 2018 · FDA recall Z-0811-2018 · NxStage Medical
Hazard
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. · FDA Class II
Units
16,039 cases/2 units
Sold at
Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
Description
May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
Product
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories
Manufacturer(s)
NxStage Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →