Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 19, 2020
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Cardiac Assist, Inc recalled TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The f… - a moderate-severity action.
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The f… was recalled by Cardiac Assist, Inc in February 19, 2020. Reason: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.. Check the official notice for the remedy. Verify recall #Z-1106-2020 with the FDA Devices before acting.
The recall
Cardiac Assist, Inc issued this moderate-severity FDA Devices recall-The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula..
- Moderate
- severity level
- Class II
- classification
- February 19, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1106-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1106-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on November 19, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardiac Assist, Inc is listed as the recalling firm, operating out of Pittsburgh, PA. Federal records list the affected scope as 11 kits.
The documented reason for this recall is: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AZ, AL, ME, LA, PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11 kits
Related Recalls
6
3 from same agency
Product description
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Reason for recall
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1106-2020 |
| Date reported | February 19, 2020 |
| Date initiated | November 19, 2019 |
| Recalling firm | Cardiac Assist, Inc |
| Firm location | Pittsburgh, PA |
| Affected scope | 11 kits |
| Distribution | US Nationwide distribution in the states of AZ, AL, ME, LA, PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1106-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.. Recalled by Cardiac Assist, Inc. Units affected: 11 kits.
Why was this product recalled? ▼
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1106-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AZ, AL, ME, LA, PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1106-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 19, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.