Z-0411-2022Class II

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN...

Name: Z-0411-2022 regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN...
Creator: ROi CPS LLC
Published: 2021-11-04
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-11-04 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles on 2021-11-04. FDA classified it as Class II and gives the reason as "The kit contains a non-sterile needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-04
Posted: 2021-12-22
Terminated: 2023-08-07
Recalling firm: ROi CPS LLC
Product: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Product code: MLS Labor And Delivery Kit
Reason for recall: The kit contains a non-sterile needle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 40 kits
Distribution: Distribution was made to Missouri. There was no foreign/military/government distribution.
Product codes and lots: Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code MLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)