Cardiac Assist Recalls TandemLife ECLS Procedure Kits with Incorrect Cannula

Plain-English summary

Cardiac Assist, Inc. is recalling 11 units of the TandemLife ECLS Procedure Kit, Catalog Number 5740-2417. The recall was initiated because the kits contained a 29Fr ProtekDuo cannula instead of the intended 24Fr Protek Solo Venous cannula. The 24Fr Protek Solo Venous cannula is intended to provide a conduit for blood to travel from the patient's venous system when connected to accessory extracorporeal equipment.

The affected kits were distributed nationwide in the states of Arizona, Alabama, Maine, Louisiana, and Pennsylvania. The specific serial numbers and UDI codes for the affected units are listed in the source data, with an expiration date of August 25, 2020 for all products.

Healthcare facilities and consumers should stop using the affected kits and contact Cardiac Assist, Inc. for instructions on return or replacement. These devices are intended for use by trained physicians only.

The recalled product

Product

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 Can

Manufacturer

Cardiac Assist, Inc

Category

Medical Device — Extracorporeal Circulatory Support

Hazard

• component-mismatch
• device-malfunction

Affected units

11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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