Z-1191-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- January 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 693
Product Description
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.
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.
Distribution Pattern
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.
Code Information
UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019