Home / Recalls / ROi CPS LLC / Z-0596-2024

Z-0596-2024 Class I Terminated

Recalled by ROi CPS LLC — Republic, MO

Recall Details

Product Type
Devices
Report Date
January 10, 2024
Initiation Date
November 20, 2023
Termination Date
August 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1830 units

Product Description

Regard Dressing change kit, Item Number 800026006

Reason for Recall

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Distribution Pattern

US Nationwide distribution in the state of Louisiana.

Code Information

UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270

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-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-1431-2023 Class II — Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C (March 22, 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)