FDA Device recall Z-0411-2022
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles
- FDA Device
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles by Roi Cps, citing the kit contains a non-sterile needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0411-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-04 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | MO |
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.
Identifiers
| code_info | Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0411-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.