Cardiac Assist, Inc: 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 f

Is my product affected?

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 c

• UPC 00814112020517

Check against the official notice below — it lists the full affected range.

What happened

Cardiac Assist, Inc. is recalling 11 units of the TandemLife ECLS Procedure Kit (Catalog Number 5740-2417) that were distributed nationwide to Arizona, Alabama, Maine, Louisiana, and Pennsylvania. The kits contained a 29Fr ProtekDuo cannula instead of the correct 24Fr Protek Solo Venous cannula, which is designed to provide a conduit for blood to travel during the procedure. The affected kits have serial numbers 141445 through 141454 and 141457, with an expiration date of August 25, 2020.

The recall record does not specify what an affected consumer should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. Distribution: US Nationwide distribution in the states of AZ, AL, ME, LA, PA. Quantity: 11 kits Lot/code info: Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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