Recall Z-1483-04 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Datascope Corp
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
| Date | Sep 21, 2004 (initiated Jul 28, 2004) |
| Status | Terminated |
| Reason | The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex. |
| Root cause | Other |
| 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. |
| Quantity | 146 |
| Distribution | Product was shipped to hospitals and medical clinics nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032338 | TRIO MONITOR MODEL 0998-00-0600 Datascope Corp., Feb 11, 2004 |