Recall archive / FDA device enforcement
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles. — FDA record Z-0411-2022
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 Nov 4, 2021. 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 Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
- Reason
- The kit contains a non-sterile needle.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 40 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0411-2022
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 #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to Missouri. 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
- Dec 29, 2021
- Recall initiation date
- Nov 4, 2021
- Center classification date
- Dec 22, 2021
- Termination date
- Aug 7, 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.