Recall archive / FDA device enforcement
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. — FDA record Z-1408-2022
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 Jun 3, 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
- Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
- Reason
- Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 40 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-1408-2022
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 #92605, exp. 8/31/2023, Item #830014016, UDI #10194717110156. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to MO. There was no foreign/military/government distribution.
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
- Jul 27, 2022
- Recall initiation date
- Jun 3, 2022
- Center classification date
- Jul 19, 2022
- Termination date
- Apr 14, 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.