Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits
Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may result in fluid leaks during dialysis treatment. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary recall for 211 units of the Phoenix Dialysis Machine Preventive Maintenance Kit (Code 6997266). The affected lots are 1607250, 160824D, 161005D, and 161026D. These kits were distributed nationwide.
The recall is due to incorrect silicone straight connectors packaged in the kits. The connectors included in the FILTER sub-group are larger than expected. During preventive maintenance, these specific connectors must only be installed in the Phoenix mass-balance section of the hydraulic circuit if the machine has already been modified with the "CONN. IMPROVING RETR. KIT" (Code SP00721). Installing these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment.
The Phoenix Hemodialysis delivery system is intended for use in chronic care dialysis facilities or acute care units by trained operators. Healthcare facilities should check their inventory for the affected lot codes and stop using the recalled kits. Patients should contact their dialysis provider if they have questions regarding their treatment equipment.
The recalled product
- Product
- Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or lo
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 211
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product code: 6997266
- Lot codes: 1607250
- 160824D
- 161005D
- 161026D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · fluid leak
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- SevereIC Bus school bus brake lines may be damaged and leak
NHTSA · 2026-02-26
- HighNeedle free access connectors recalled over silicone seals that may tear
FDA (Devices) · 2026-01-28
- ModerateProcedure kits recalled over suction irrigators that can leak during use
FDA (Devices) · 2026-01-21