Home / Recalls / Resource Optimization & Innovation LLC / Z-2369-2020

Z-2369-2020 Class II Terminated

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

FDA device recall Z-2369-2020 was initiated by Resource Optimization & Innovation LLC on May 4, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 23, 2022). Affected quantity: 12,640 units.

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
12,640 units

Product Description

Regard SRHS Central Line Kit, Sterile, 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 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.

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-2368-2020 Class II — Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Fl (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-1628-2017 Class II — Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa R (January 9, 2017)
  • Z-1657-2017 Class II — Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn (January 9, 2017)
  • Z-1675-2017 Class II — Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa (January 9, 2017)
  • Z-1635-2017 Class II — Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highla (January 9, 2017)
  • Z-1604-2017 Class II — Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center San (January 9, 2017)

FDA data resources