Recall archive / FDA device enforcement
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit — FDA record Z-0301-2023
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 Oct 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 VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
- Reason
- Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 8 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0301-2023
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 | UDI/DI 10194717109297, Lot Numbers: 92327, exp 4/26/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
LA, MO, NC, FL
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 30, 2022
- Recall initiation date
- Oct 20, 2022
- Center classification date
- Nov 23, 2022
- Termination date
- Apr 1, 2026
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.