Baxter Healthcare Corporation: complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Agency Publication Date: February 16, 2021

Affected Products

Product: 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.

UDI 07332414007836, All lots within expiry

Product: Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

UDI 07332414007881, All lots within expiry

Product: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

UDI 07332414007812, All lots within expiry

Product: 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.

UDI 07332414085216, All lots within expiry

Product: 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.

UDI 07332414112394, All lots within expiry

Product: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

UDI 07332414112400, All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87150

Status: Active

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 6 products (7437480 units; 385 devices; 1460 devices; 211155 devices; 57825 devices; 25785 devices)

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Sources: FDA iRES · Raw API Response

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