Z-1122-2021 Class II Ongoing
FDA device recall Z-1122-2021 was initiated by Baxter Healthcare Corporation on Dec 30, 2020 and is designated Class II. Reason for recall: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. The recall status is ongoing. Affected quantity: 57825 devices.
Recall details
- Product Type
- Devices
- Report Date
- Feb 24, 2021
- Initiation Date
- Dec 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57825 devices
Product description
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason for recall
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Distribution pattern
Worldwide distribution.
Code information
UDI 07332414112394, All lots within expiry
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1122-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026