Z-1056-2017 Class II Terminated
FDA device recall Z-1056-2017 was initiated by Baxter Healthcare Corporation on Dec 16, 2016 and is designated Class II. Reason for recall: Customer complaints received for the presence of leaks The recall status is terminated (terminated Aug 24, 2017). Affected quantity: 8640 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Dec 16, 2016
- Termination Date
- Aug 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8640 eaches
Product Description
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
Reason for Recall
Customer complaints received for the presence of leaks
Distribution Pattern
US only
Code Information
H16F16088
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1056-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026