Recall Z-1191-2024 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage MDS Corporation
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.
| Date | Feb 27, 2024 (initiated Jan 29, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183158 | NxStage Cartridge Express with Speedswap Nxstage Medical, Inc., Aug 9, 2019 |