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.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
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.
Kinked access lines during hemodialysis treatments can cause treatment complications. The issue was reported by users but does not indicate a risk of serious injury or death in normal use.
Hemodialysis patients using the Gambro Cartridge Blood Transport System with product code 109536 are affected. Patients using the system for single hemodialysis treatments are most at risk.
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.
Look for product code 109536 on the Gambro Cartridge Blood Transport System.
The recall is due to complaints of kinked access lines observed during hemodialysis treatments using the cartridge sets.
The official recall notice does not mention a fix or remedy for this issue.
Check for product code 109536 on the Gambro Cartridge Blood Transport System, which is intended for single use in hemodialysis treatments with the Phoenix Dialysis Delivery Systems.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1121-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1121-2021 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.