FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1191-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1191-2024
- Event ID
- 93886
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- NxStage MDS Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- January 29, 2024
- Classification Date
- February 27, 2024
- Address
- 350 Merrimack St, Lawrence, MA, 01843-1748, United States
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
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.
Code Info
UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
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.
Quantity
693