Home / Recalls / Resource Optimization & Innovation LLC / Z-2699-2020

Z-2699-2020 Class II Terminated

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

FDA device recall Z-2699-2020 was initiated by Resource Optimization & Innovation LLC on June 17, 2020 and is designated Class II. Reason for recall: The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use. The recall status is terminated (terminated July 29, 2022). Affected quantity: 66 cases of 12,000 units per case.

Recall Details

Product Type
Devices
Report Date
August 5, 2020
Initiation Date
June 17, 2020
Termination Date
July 29, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
66 cases of 12,000 units per case

Product Description

regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.

Reason for Recall

The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.

Distribution Pattern

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

Code Information

Lot 719

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-2369-2020 Class II — Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush (May 4, 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