Home / Recalls / ROi CPS LLC / Z-1407-2022

Z-1407-2022 Class II Terminated

Recalled by ROi CPS LLC — Republic, MO

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
June 3, 2022
Termination Date
April 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
86 kits

Product Description

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

Reason for Recall

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

Distribution Pattern

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

Code Information

(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

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-1433-2023 Class II — Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WP (March 22, 2023)
  • Z-1436-2023 Class II — Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C- (March 22, 2023)
  • Z-1437-2023 Class II — Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0096 (March 22, 2023)