Home / Recalls / ROi CPS LLC / Z-0411-2022

Z-0411-2022 Class II Terminated

Recalled by ROi CPS LLC — Republic, MO

Recall Details

Product Type
Devices
Report Date
December 29, 2021
Initiation Date
November 4, 2021
Termination Date
August 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 kits

Product Description

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

Reason for Recall

The kit contains a non-sterile needle.

Distribution Pattern

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

Code Information

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

Other recalls by ROi CPS LLC

  • Z-1047-2025 Class I — regard Item Number: 830106006, LD01114F - Newborn Kit containing the component N (December 26, 2024)
  • Z-3159-2024 Class II — regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 8 (July 24, 2024)
  • Z-2685-2024 Class II — Regard Kit containing the Microtek decanter (June 17, 2024)
  • Z-0620-2024 Class I — regard Operative LAP, Item Number 800943001; surgical convenience kit (December 18, 2023)
  • Z-0596-2024 Class I — Regard Dressing change kit, Item Number 800026006 (November 20, 2023)
  • Z-0315-2024 Class II — Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenienc (September 21, 2023)
  • Z-0070-2024 Class II — GS0008 2Y - Burn Pack - STL, Item Number 880082025 (September 11, 2023)
  • Z-1432-2023 Class II — Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I (March 22, 2023)
  • Z-1434-2023 Class II — Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Ca (March 22, 2023)
  • Z-1433-2023 Class II — Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WP (March 22, 2023)