Fenwal CATSmart Vacuum Unit Recall: Failure Message During Use

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Recalling firmFenwal Inc3 Corporate Dr Ste 300, N/A · Lake Zurich, IL 60047-8930

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Fenwal is recalling certain CATSmart Vacuum Units that may stop working and show a 'Failure vacuum unit' message during use. This could lead to interruptions in blood processing for medical procedures.

Why it’s dangerous

The vacuum unit may malfunction during blood processing, causing it to display a failure message. This could interrupt the blood processing cycle and potentially lead to incomplete blood collection or reinfusion.

Who’s affected

Patients using Fresenius CATSmart (Continuous Autotransfusion System) for blood processing after surgery are most at risk. The affected units have specific serial numbers listed in the recall.

How to tell if you have this one

Check the serial number on the vacuum unit. Affected units have serial numbers starting with 5VTA0180 through 7VTA0957 as listed in the recall notice.

Brand
Fenwal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Vacuum Unit Serial Number
Look for the serial number on the vacuum unit to confirm if it is in the affected range (5VTA0180 to 7VTA0957).
Contact Manufacturer for Details
If the unit is affected, contact Fenwal directly for further instructions on how to address the issue.

✎ GovInfoNow

Questions people ask

What is the specific hazard with these vacuum units?

The vacuum unit may stop working and display the failure message 'Failure vacuum unit' during use, which could interrupt blood processing.

How can I tell if my vacuum unit is affected?

Check the serial number on the unit. Affected units have serial numbers starting with 5VTA0180 through 7VTA0957 as listed in the recall.

What should I do if my unit is affected?

Contact Fenwal directly for further instructions on how to address the issue.

Take action

Contact Fenwal

We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1059-2019 — Fenwal Fenwal

Hello,

I own a Fenwal that is covered by recall Z-1059-2019 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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Where this comes from

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.

Official source: FDA Recall #Z-1059-2019 (February 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1059-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Fenwal Inc recalls Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the

Use caution until it’s fixed