Home / Recalls / Resource Optimization & Innovation LLC / Z-2368-2020

Z-2368-2020 Class II Terminated

Recalled by Resource Optimization & Innovation LLC — Saint Louis, MO

Recall Details

Product Type
Devices
Report Date
June 24, 2020
Initiation Date
May 4, 2020
Termination Date
September 23, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,360 units

Product Description

Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.

Reason for Recall

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Distribution Pattern

US Nationwide distribution including in the states of MO, NC.

Code Information

Item number 303394REG: lot numbers: 259427, 262441, 264440, 268589, 268915, 271008, and 269694.

Other recalls by Resource Optimization & Innovation LLC

  • Z-0950-2022 Class II — Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous (February 28, 2022)
  • Z-2699-2020 Class II — regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576RE (June 17, 2020)
  • Z-2369-2020 Class II — Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush (May 4, 2020)
  • Z-0169-2018 Class II — Regard Custom Surgical Pack Packs contain surgical instruments and accessorie (September 25, 2017)
  • Z-1652-2017 Class II — Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn (January 9, 2017)
  • Z-1675-2017 Class II — Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa (January 9, 2017)
  • Z-1553-2017 Class II — Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hill (January 9, 2017)
  • Z-1589-2017 Class II — Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills (January 9, 2017)
  • Z-1635-2017 Class II — Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla (January 9, 2017)
  • Z-1608-2017 Class II — Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center (January 9, 2017)