Baxter Healthcare recalls Gambro Cartridge Blood Transport Systems for hemodialysis due to potential tubing disconnection during use. Affected units have specific lot numbers and product codes.
Potential disconnection of tubing set.
Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis treatments because they might disconnect during use. This could lead to blood loss or treatment interruption if not fixed.
The tubing set might disconnect during hemodialysis treatment, which could cause blood loss or interruption of the treatment process. This is a potential risk when the system is used as intended for single-use hemodialysis.
Hemodialysis patients using the Gambro Cartridge Blood Transport System with specific lot numbers are affected. Patients using the system for single-use hemodialysis treatments are most at risk.
Check for product code 109536 and lot numbers 1000205902, 1000214627, 1000222392, or 1000226807 on the packaging or label. The system is intended for single-use in hemodialysis treatments using Dialysis Delivery Systems.
Look for product code 109536 and lot numbers listed in the recall notice to confirm if your system is affected.
The recall states the product is intended for single-use in hemodialysis treatments, but potential disconnection during use makes it unsafe without correction.
The recall does not specify a remedy, so you should check the product details to see if it is affected and contact your healthcare provider for guidance.
Check for product code 109536 and lot numbers 1000205902, 1000214627, 1000222392, or 1000226807 on the packaging or label.
We’ve drafted a message you can send Gambro to request your refund or repair — edit it as you like.
Subject: Recall Z-2194-2020 — Gambro Gambro Hello, I own a Gambro that is covered by recall Z-2194-2020 from Gambro. 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.
