Fenwal recalls CATSmart Continuous autotransfusion systems with specific model numbers and serial ranges due to risk of centrifuge tubing puncture during surgery.
Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of the tubing.
Fenwal is recalling CATSmart Continuous autotransfusion systems that may cause tubing puncture during surgery. This could lead to excessive wear or injury if the tubing contacts the washing chamber.
The device's centrifuge tubing may contact the washing chamber during use, causing excessive wear or punctures. This could lead to blood leaks or infections if not properly managed.
Surgical teams using the CATSmart device for autologous blood reinfusion during surgery or trauma treatment are most at risk. Patients receiving this device for blood processing are affected.
Check for model numbers: AT-1 sets (9005104, 9108504, 9108494) or AT-3 sets (9005444, 9104444, 9108444). Look for serial numbers starting with 6CTA, 7CTA, or 8CTA followed by specific digits.
Look for serial numbers starting with 6CTA, 7CTA, or 8CTA followed by specific digits listed in the recall notice.
Reach out to Fenwal for guidance on whether your device is affected and next steps.
The recall indicates a risk of tubing puncture during use, so it's recommended to stop using affected devices until the manufacturer provides guidance.
Check your device's serial number against the list provided in the recall notice. If affected, contact Fenwal for instructions.
Affected devices have serial numbers starting with 6CTA, 7CTA, or 8CTA followed by specific digits listed in the recall notice.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-1209-2019 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-1209-2019 from Fenwal. 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.
