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U.S. Department of Health and Human Services

Class 2 Device Recall NxStage Cartridge Express with Speedswap

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  Class 2 Device Recall NxStage Cartridge Express with Speedswap see related information
Date Initiated by Firm January 29, 2024
Date Posted February 27, 2024
Recall Status1 Open3, Classified
Recall Number Z-1191-2024
Recall Event ID 93886
510(K)Number K183158  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product NxStage Cartridge Express with Speedswap, Catalog No. CAR-535.

An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
Code Information UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
Recalling Firm/
NxStage MDS Corporation
350 Merrimack St
Lawrence MA 01843-1748
For Additional Information Contact NxStage Medical
Manufacturer Reason
for Recall
Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
FDA Determined
Cause 2
Component design/selection
Action The firm began notifying affected customers on January 29, 2024. Customers were informed that the issue may occur when the needleless access port located next to the filter has been accessed and there is a buildup of pressure in the circuit. Customers were instructed to inspect their inventory for affected product and quarantine recalled product. Customers should not use affected product and should ensure all users of the CAR-535 are aware of the notice. Customers should contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) to arrange for the return of all affected products. This number may also be contacted if you have any questions or comments.
Quantity in Commerce 693
Distribution US domestic distribution to Dialysis Centers located in AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI. No international distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = NxStage Medical, Inc.