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Terminated

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.

FDA Recall Z-2550-2018 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeOEZ
Date Initiated2017-05-12
Date Terminated2018-10-26
Product Quantity30 cases/2 units (Total 60 units)

Reason for Recall

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

Firm Action

On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US state of FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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