Use caution Medical device recall · FDA · Published March 5, 2019

Fenwal CATSmart device recall: Risk of tubing puncture during surgery

Fenwal recalls CATSmart Continuous autotransfusion systems with specific model numbers and serial ranges due to risk of centrifuge tubing puncture during surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1209-2019Medical device Fenwal ›

Use caution until it’s fixed

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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/68913-fenwal-catsmart-device-recall-risk-of-tubing-puncture-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/68913-fenwal-catsmart-device-recall-risk-of-tubing-puncture-during-surgery · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1209-2019

Cite this page

“Fenwal CATSmart device recall: Risk of tubing puncture during surgery.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68913-fenwal-catsmart-device-recall-risk-of-tubing-puncture-during-surgery. Based on FDA recall #Z-1209-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2019%22&limit=1).

The FDA announced on March 5, 2019, that Fenwal Inc is recalling its CATSmart device (Continuous autotransfusion System) and associated kits due to a hazard involving centrifuge tubing contact with the washing chamber. This defect may result in excessive wear or puncture of the tubing.

How to tell if you have it

Brand: Fenwal
Product: CATSmart device (Continuous autotransfusion System)
Kits: AT-1 sets and kits (9005104, 9108504, 9108494); AT-3 Autotransfusion sets and kits (9005444, 9104444, 9108444)
Product Code: 9005901
Lot Numbers: Beginning with GM or H
Serial Numbers: 6CTA0209 through 6CTA0309; 7CTA0328 through 7CTA0740; 8CTA0741 through 8CTA1057 (including specific listed numbers)
Distribution: Worldwide, including US states AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, PR, and Canada

The hazard

Based on internal investigations, Fresenius Kabi identified events where the centrifuge tubing line may make contact with the washing chamber. This contact may result in excessive wear of the centrifuge tubing or, in extreme cases, a puncture of the tubing.

Context

GovInfoNow's records show Fenwal Inc has issued four other recalls since February 11, 2019. On June 24, 2019, the firm recalled Volumat MC Agilia Infusion Pump Software to correct safety anomalies and alarm priority issues. Other recent recalls of similar products include Medline Convenience Kits Recall (May 28, 2026), Medline Convenience Kits with Swan-Ganz Catheters Recalled Due to Leak Risk (May 28, 2026), and Stryker BARD EP XT Steerable Catheter Recall (April 10, 2026).

How to tell if you have this one

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.

Brand
Fenwal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Numbers
Look for serial numbers starting with 6CTA, 7CTA, or 8CTA followed by specific digits listed in the recall notice.
Contact Manufacturer
Reach out to Fenwal for guidance on whether your device is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 32 states.

FDA distribution: “Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and PR, and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Mar 5, 2019Firm started the recall
Apr 23, 2019FDA classified it Class II
May 1, 2019Published in FDA’s Enforcement Report
Oct 5, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this device safe to use?

The recall indicates a risk of tubing puncture during use, so it's recommended to stop using affected devices until the manufacturer provides guidance.

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Link to this recall

<a href="https://govinfonow.com/recall/68913-fenwal-catsmart-device-recall-risk-of-tubing-puncture-during-surgery">Fenwal CATSmart device recall: Risk of tubing puncture during surgery (GovInfoNow)</a>

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-1209-2019 (March 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1209-2019 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.