Medical device recalls Moderate risk

Terumo Cardiovascular Systems Corp recalls Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of t…

Recall date
May 12, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2550-2018
FDA classification
Class II
Brand / firm
Terumo Cardiovascular Systems Corp
Sold / distributed
US state of FL

Why it was recalled

Kit was labeled with the incorrect Expiration Date of April 30, 2019.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

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