Use cautionMedical device recall · FDA · Published April 14, 2021
Baxter Gambro Cartridge Blood Set Recall: Potential Leak Risk in Hemodialysis
Baxter recalls Gambro Cartridge Blood Set (Product Code 101025) used in hemodialysis due to potential leak between venous connector and patient access. Affected units sold with specific lot numbers and UDI codes.
There is a potential leak between the venous patient connector and patient's hemodialysis access.
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Contact the company
📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer
Baxter is recalling Gambro Cartridge Blood Sets used in hemodialysis treatments because they may leak between the venous connector and patient access. This leak could cause blood loss or infection risks during dialysis. Affected units have specific product codes and lot numbers. Read more at govinfonow.com/recall/62791-baxter-gambro-cartridge-blood-set-recall-potential-leak-risk-in.
“Baxter Gambro Cartridge Blood Set Recall: Potential Leak Risk in Hemodialysis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62791-baxter-gambro-cartridge-blood-set-recall-potential-leak-risk-in. Based on FDA recall #Z-1684-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1684-2021%22&limit=1).
Baxter Healthcare Corporation voluntarily recalled the Gambro Cartridge Blood Set, Product Code 101025, due to a potential leak between the venous patient connector and the patient's hemodialysis access, according to the FDA. The agency announced the Class II recall on April 14, 2021.
How to tell if you have it
Brand: Baxter
Product: Gambro Cartridge Blood Set
Product Code: 101025
Lot Code: 1000276191
UDI: 37332414007837
Units affected: 17,487
The hazard
The recall addresses a potential leak between the venous patient connector and the patient's hemodialysis access. The Gambro Cartridge Blood Set is intended for single use in hemodialysis treatment using Phoenix Dialysis Delivery Systems.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Other recent recalls of similar products include the Fresenius Medical Care 5008X Blood Tubing Set (August 10, 2026), the Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set (August 10, 2026), and the B Braun Medical Blood Set (October 29, 2025).
How to tell if you have this one
Check for Product Code 101025 on the blood set. Affected units were sold with Lot 1000276191 and UDI code 37332414007837.
Brand
Baxter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for Product Code 101025 on the blood set to confirm if it's affected.
Contact Baxter
Reach out to Baxter Healthcare Corporation for assistance with the recall if you have the affected product code.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1684-2021 (April 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1684-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.