Severity
Moderate
Maintenance Kit PH2, Cod. 6997274 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 low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Reported: February 1, 2017 Initiated: January 4, 2017 #Z-1095-2017 256 kits units
Baxter Healthcare Corporation issued this FDA Devices recall on February 1, 2017. Classified as Moderate severity (Class II). Approximately 256 kits units are affected. The recall was issued because: Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preven…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1095-2017) was formally reported on February 1, 2017, with the manufacturer initiating the action on January 4, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records indicate 256 kits units are affected.
The documented reason for this recall is: Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kit… Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
256 kits
Related Recalls
6
6 from same agency
Product Description
Maintenance Kit PH2, Cod. 6997274 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 low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Reason for Recall
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 256 kits
- Distribution
- Nationwide Distribution
- Location
- Deerfield, IL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1095-2017 |
| Date reported | February 1, 2017 |
| Date initiated | January 4, 2017 |
| Recalling firm | Baxter Healthcare Corporation |
| Units affected | 256 kits |
| Distribution | Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Maintenance Kit PH2, Cod. 6997274 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 low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit. Recalled by Baxter Healthcare Corporation. Units affected: 256 kits.
Why was this product recalled? ▼
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2017. Severity: Moderate. Recall number: Z-1095-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1095-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).