Recall archive / FDA device enforcement
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit — FDA record Z-0315-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Reason
- Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 134 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0315-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MO
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 22, 2023
- Recall initiation date
- Sep 21, 2023
- Center classification date
- Nov 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.