NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
FDA Recall Z-0826-2012 · Posted 2012-01-20
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Recalling FirmNxStage Medical, Inc.
Recall StatusTerminated
Product CodeFKR
Date Initiated2011-12-14
Date Terminated2012-04-17
Product Quantity1,192 devices
Reason for Recall
Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
Firm Action
On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided.
If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).
Root Cause
Employee error
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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