NxStage recalls specific cartridge models for blood leakage risk during renal treatment. Affected units may cause uncontrolled bleeding or expose healthcare workers to infectious blood. Contact for replacement.
Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
NxStage is recalling certain Cartridge Express with Speedswap models used in renal care due to reported blood leaks. This could lead to uncontrolled bleeding for patients or expose healthcare workers to infectious blood.
The cartridge can leak blood from the arterial line during use, potentially causing uncontrolled bleeding in patients. Healthcare workers could also be exposed to infectious blood if the leak occurs.
Healthcare professionals using the recalled cartridges for renal patients and patients receiving treatment with these devices are most at risk. The specific models are used in acute and chronic renal failure or fluid overload management.
Check for the catalog number CAR-535 on the cartridge packaging. The affected units have UDI-DI M535CAR5350 and package DI M535CAR5355 with specific production lots listed in the recall notice.
Inspect the cartridge for blood leaking from the arterial line during use.
Reach out to NxStage MDS Corporation for replacement or guidance on safe use.
The cartridge has reported blood leaks that could cause uncontrolled bleeding in patients or expose healthcare workers to infectious blood.
The specific model is the NxStage Cartridge Express with Speedswap, Catalog No. CAR-535 with UDI-DI M535CAR5350 and package DI M535CAR5355 in certain production lots.
Check the cartridge packaging for the catalog number CAR-535 and the specific production lots listed in the recall notice.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-1191-2024 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-1191-2024 from NxStage. 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.
