Gambro Cartridge Blood Set Prime Line, product code 101025… recallZ-1118-2021 · Baxter Healthcare Corporation · initiated Dec 30, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm issued a Safety Alert on 12/30/2020 by mail. The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line. Customers identifying set with kinked tubing may contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Distributor were asked to notify their customers by distributing the letter.
Recall details
- Recall number
- Z-1118-2021
- Status
- Open, Classified
- Initiated by the company
- Dec 30, 2020
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 7437480 units
- Product code
- FJK
- FDA submissions
- K070414
- Distribution
- Worldwide distribution.
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.
Code information (models, lots, serial numbers)
UDI 07332414007836, All lots within expiry
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cartridge Blood Set 101025Gambro Renal Products, S.A. de C.V. · SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE3 recalls80 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87150).
- Z-1119-2021 · Open, ClassifiedGambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Z-1120-2021 · Open, ClassifiedGambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialy…
- Z-1121-2021 · Open, ClassifiedGambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialy…
- Z-1122-2021 · Open, ClassifiedGambro 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 Ph…
- Z-1123-2021 · Open, ClassifiedGambro 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 u…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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