Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label

Plain-English summary

Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31, a medical device kit used for temporary cardiopulmonary bypass. The recall was initiated due to incorrect expiration date labeling on the outer package. While the top label correctly shows an expiration date of May 1, 2022, the side label displays an incorrect expiration date of May 1, 2021.

The recalled units were distributed to healthcare facilities in Washington DC, Massachusetts, South Carolina, and Virginia. The affected serial numbers are 872170, 872171, 872172, 872173, 872182, 872183, and 872184.

Healthcare providers who have received this product should verify the correct expiration date using the top label and disregard the incorrect date shown on the side label. No injuries or illnesses have been reported related to this labeling error.

The recalled product

Product

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable

Manufacturer

Cardiac Assist, Inc

Category

Medical Device — Cardiopulmonary Bypass Equipment

Hazard

• expiration-date-mislabel

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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