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Terminated

Cardiovascular Procedure Kit catalog # 76645 & 73806

FDA Recall Z-0949-2022 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeOEZ
Date Initiated2022-02-03
Date Terminated2024-02-20
Product Quantity64

Reason for Recall

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

Firm Action

A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CA and IN.

Official Source

View FDA Recall →

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

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