Baxter Healthcare recalls Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis due to reported kinked access lines during treatments. Affected units include product code 11443: 07332414112400.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis treatments because users reported kinked access lines during dialysis. This could lead to treatment complications if not addressed.
Kinked access lines during hemodialysis treatments can cause blockages or treatment interruptions. This may lead to complications like reduced blood flow or treatment failure if not corrected.
Hemodialysis patients using the Gambro blood set with product code 114435 are affected. Patients using the system with the UDI 07332414112400 are most at risk.
Check for the product code 114435 on the Gambro blood set. The unique device identifier (UDI) 07332414112400 applies to all affected units within their expiry date.
Inspect the blood set for kinked access lines before each use during hemodialysis treatments.
Yes, if you use the Gambro Cartridge Low Weight-Low Volume Blood Transport System with product code 114435 for hemodialysis, you may have kinked access lines.
Look for the product code 114435 and unique device identifier (UDI) 07332414112400 on the blood set.
Inspect the blood set for kinks before each use during hemodialysis treatments.
We’ve drafted a message you can send Gambro to request your refund or repair — edit it as you like.
Subject: Recall Z-1123-2021 — Gambro Gambro Hello, I own a Gambro that is covered by recall Z-1123-2021 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.