Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reported: February 24, 2021 Initiated: December 30, 2020 #Z-1121-2021
Product Description
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - 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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 211155 devices
- Distribution
- Worldwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.. Recalled by Baxter Healthcare Corporation. Units affected: 211155 devices.
Why was this product recalled? ▼
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1121-2021.
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