Lower risk Medical device recall · FDA · Published December 30, 2020

Baxter Gambro Cartridge Blood Transport System Recall: Kinked Lines During Hemodialysis

Baxter recalls Gambro Cartridge Blood Transport System for hemodialysis blood sets due to kinked access lines observed during treatment. Affected units may cause treatment complications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1121-2021Medical device Baxter ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

✎ GovInfoNow plain-language explainer

Baxter is recalling Gambro Cartridge Blood Transport System blood sets for hemodialysis treatments because users reported kinked access lines during dialysis. This could lead to treatment complications if the lines become kinked. Read more at govinfonow.com/recall/63583-baxter-gambro-cartridge-blood-transport-system-recall-kinked-lines-during.

Source Summary by GovInfoNow · govinfonow.com/recall/63583-baxter-gambro-cartridge-blood-transport-system-recall-kinked-lines-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1121-2021

Cite this page

“Baxter Gambro Cartridge Blood Transport System Recall: Kinked Lines During Hemodialysis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63583-baxter-gambro-cartridge-blood-transport-system-recall-kinked-lines-during. Based on FDA recall #Z-1121-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2021%22&limit=1).

Baxter Healthcare Corporation voluntarily recalled the Gambro Cartridge Blood Transport System for Hemodialysis Blood Set on Dec. 30, 2020, according to the FDA. The recall addresses complaints of kinked access lines observed during hemodialysis treatments.

How to tell if you have it

Brand: Baxter
Product: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set
Product code: 109536
UDI: 07332414085216
Lots: All lots within expiry
Units affected: 211,155 devices

The hazard

The FDA reported that complaints of kinked access lines were observed during treatment using the cartridge sets for hemodialysis treatments.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls of similar products include Fresenius Medical Care 5008X Blood Tubing Set Recall (Aug. 10, 2026), B Braun Hemodialysis Bloodlines Recall (March 19, 2026), and another B Braun Hemodialysis Bloodlines Recall (March 19, 2026).

How to tell if you have this one

Check for the product code 1095:36 on the Gambro Cartridge Blood Transport System. The system is intended for single use in hemodialysis treatments with the Phoenix Dialysis Delivery Systems.

Brand
Baxter
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1118-2021	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	7437480 units
Z-1119-2021	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	385 devices
Z-1120-2021	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	1460 devices
Z-1121-2021	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	211155 devices
Z-1122-2021	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	57825 devices
Z-1123-2021	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	25785 devices

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for product code 109536 on the Gambro Cartridge Blood Transport System.

How this recall unfolded

Recall timeline

FDA published this recall 56 days after the firm started it.

Dec 30, 2020Firm started the recall
Feb 16, 2021FDA classified it Class II
Feb 24, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Baxter recalls

Latest medical device recalls

Keep exploring

More Baxter recalls

Link to this recall

<a href="https://govinfonow.com/recall/63583-baxter-gambro-cartridge-blood-transport-system-recall-kinked-lines-during">Baxter Gambro Cartridge Blood Transport System Recall: Kinked Lines During Hemodialysis (GovInfoNow)</a>

Where this comes from

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-1121-2021 (December 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1121-2021 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.