ROi CPS LLC: Medical Device Recall in 2021 - (Recall #: Z-0411-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 4, 2021

Date Posted: December 29, 2021

Recall Number: Z-0411-2022

Event ID: 89078

Reason for Recall:

The kit contains a non-sterile needle.

Status: Terminated

Product Quantity: 40 kits

Code Information:

Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.

Distribution Pattern:

Distribution was made to Missouri. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated