NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-

FDA device recall Z-2160-2024 · posted 2024-06-20 · Open, Classified

Recall details

Recalling firm

NxStage Medical Inc

Reason for recall

The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.

Action taken

An URGENT MEDICAL DEVICE RECALL dated 5/14/24 was sent to customers. Action to be taken by Customers 1. Check all boxes in your Pureflow B solution inventory. If you find any boxes or individual bags of Pureflow B solution from the affected lots, separate them from your other inventory and do not use them. (Refer to Appendix B for how to locate lot number). 2. Follow the instructions on the attached reply form to acknowledge your receipt of this notice. 3. Contact NxStage Customer Service (acuteorders@freseniusmedicalcare.com) to arrange for the return of all affected product. We understand that dialysis fluids are critical to patient care, and immediately removing these fluids from your facility may result in the inability to treat critically ill patients. If no alternatives are available, use of PPE (goggles) and activation of bags away from patients and other personnel will limit possibility of injury due to exposure to the fluid from the small chamber. Action to be taken by NxStage NxStage is sending this notice to all facilities that have received affected RFP-4XX to alert you of the issue and request return of the Product. As a result of this action, we expect a temporary shortage of some low volume formulations for approximately 2 weeks. NxStage is working diligently to ensure expedited product availability by securing additional supply via multiple channels If you have any questions or comments, please contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KPO

Quantity affected

1316936 units

Distribution

US Nationwide distribution.

Date initiated

2024-05-14

Date posted

2024-06-20

Location

Lawrence, MA

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