NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and repl
FDA device recall Z-1191-2024 · posted 2024-02-27 · Open, Classified
Recall details
- Recalling firm
- NxStage MDS Corporation
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 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.
- Date initiated
- 2024-01-29
- Date posted
- 2024-02-27
- Location
- Lawrence, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NxStage Cartridge Express with Speedswap (K183158) | Nxstage Medical, Inc. | 2019-08-09 |