Z-1118-2021 Class II Ongoing
FDA device recall Z-1118-2021 was initiated by Baxter Healthcare Corporation on December 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: 7437480 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- December 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7437480 units
Product Description
Gambro Cartridge Blood Set Prime Line, product code 101025 - 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 07332414007836, All lots within expiry