TandemLife ECLS Procedure Kit - V24/A17, Catalog Number recallZ-1106-2020 · Cardiac Assist, Inc · initiated Nov 19, 2019

Why it was recalled

The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

FDA root cause category: Employee error

What the company is doing

Initial communications were delivered verbally to quarantine devices starting November 19, 2019. Subsequently, on November 25, 2019 TandemLife issued Medical Device Correction notices to customers via letter 1st class mail (certified return receipt). Actions to be taken by the Customer 1. Check your inventory for the affected product listed within the notice 2. Discontinue use and Quarantine the product 2. Using the Response Form, please respond by email to [email protected] to confirm appropriate action has been executed. 3. A replacement TandemLife ECLS Procedure Kit V24/A17 (Reference 5740-2417) has already been shipped to your facility. Your TandemLife representative will contact you to organize the collection of the affected quarantined kit(s). 4. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware. If you have transferred any affected device to a third party, please communicate this information to them and inform TandemLife Quality Assurance Team at [email protected]. For questions regarding this Medical Device Correction, please contact your TandemLife representative, or TandemLife Customer Quality at [email protected].

Recall details

Recall number

Z-1106-2020

Status

Terminated

Initiated by the company

Nov 19, 2019

Recalling firm

Cardiac Assist, Inc

Quantity

11 kits

Product code

DWF

FDA submissions

K162214

Distribution

US Nationwide distribution in the states of AZ, AL, ME, LA, PA.

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• TandemLife 5740-2417

  Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization
  2 recalls0 reports