regard Clinical Packaging Solutions Item Number 830096005… recallZ-0411-2022 · ROi CPS LLC · initiated Nov 4, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The kit contains a non-sterile needle.
FDA root cause category: Process control
What the company is doing
The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer. The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution. The attached reply form was to be completed so that return of the affected kits could be arranged. If the kits were further distributed, the customer was requested to notify their customers.
Recall details
- Recall number
- Z-0411-2022
- Status
- Terminated
- Initiated by the company
- Nov 4, 2021
- Posted by the FDA
- Dec 22, 2021
- Recalling firm
- ROi CPS LLC
- Quantity
- 40 kits
- Product code
- MLS
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
Product description
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Code information (models, lots, serial numbers)
Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ OB01054ERoi Cps, LLC · Labor And Delivery Kit1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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