Home / Recalls / ROi CPS LLC / Z-3159-2024

Z-3159-2024 Class II Ongoing

Recalled by ROi CPS LLC — Republic, MO

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
July 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3387 kits

Product Description

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Reason for Recall

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

Distribution Pattern

US Nationwide distribution in the state of North Carolina.

Code Information

GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS

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-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-1436-2023 Class II — Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C- (March 22, 2023)
  • Z-1434-2023 Class II — Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Ca (March 22, 2023)
  • Z-1431-2023 Class II — Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C (March 22, 2023)