Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
FDA device recall Z-1483-04 · posted 2004-09-21 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
- Action taken
- 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
- Status
- Terminated
- Product code
- DRT
- Quantity affected
- 146
- Distribution
- Product was shipped to hospitals and medical clinics nationwide.
- Date initiated
- 2004-07-28
- Date posted
- 2004-09-21
- Date terminated
- 2004-11-22
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIO MONITOR MODEL 0998-00-0600 (K032338) | Datascope Corp. | 2004-02-11 |