Recall archive / FDA device enforcement
Regard brand CABG Pack A and B - Spartanburg — FDA record Z-1051-2022
Reported terminated
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 Mar 21, 2022. 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 brand CABG Pack A and B - Spartanburg
- Reason
- Kits were packed into shipping boxes incorrectly.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 85 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-1051-2022
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 | Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Recall impacted one domestic consignee in NC
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
- May 18, 2022
- Recall initiation date
- Mar 21, 2022
- Center classification date
- May 9, 2022
- Termination date
- Dec 28, 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.