Z-1095-2017 Class II Terminated
FDA device recall Z-1095-2017 was initiated by Baxter Healthcare Corporation on Jan 4, 2017 and is designated Class II. 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… The recall status is terminated (terminated Mar 8, 2019). Affected quantity: 256 kits.
Recall details
- Product Type
- Devices
- Report Date
- Feb 1, 2017
- Initiation Date
- Jan 4, 2017
- Termination Date
- Mar 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256 kits
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.
Distribution pattern
Nationwide Distribution
Code information
Product code: 6997274; Lot codes: 160718E, 160720E, 160825E
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1095-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026