Gambro Cartridge Blood Set, Product Code 101025 - Product… recallZ-1684-2021 · Baxter Healthcare Corporation · initiated Apr 14, 2021
Terminated
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
There is a potential leak between the venous patient connector and patient's hemodialysis access.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
Recall details
- Recall number
- Z-1684-2021
- Status
- Terminated
- Initiated by the company
- Apr 14, 2021
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 17,487 units
- Product code
- FJK
- FDA submissions
- K070414
- Distribution
- Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Product description
Gambro Cartridge Blood Set, 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)
Product Code: 101025; Lot 1000276191, UDI: 37332414007837
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
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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