Recall archive / FDA device enforcement
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. — FDA record Z-1295-2022
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 May 20, 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 Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
- Reason
- A nonsterile component was packaged in a sterile convenience kit.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 180 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-1295-2022
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 | Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of FL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 6, 2022
- Recall initiation date
- May 20, 2022
- Center classification date
- Jun 28, 2022
- Termination date
- May 2, 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.