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Terminated

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

FDA Recall Z-1483-04 · Posted 2004-09-21

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeDRT
Date Initiated2004-07-28
Date Terminated2004-11-22
Product Quantity146

Reason for Recall

The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

Firm Action

On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.

Root Cause

Other

Distribution Pattern

Product was shipped to hospitals and medical clinics nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032338TRIO MONITOR MODEL 0998-00-0600Datascope Corp. · 2004-02-11

Official Source

View FDA Recall →

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

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