Saint Louis, MO, United States
Resource Optimization & Innovation LLC recalls
3 recalls recorded since 2018, most recently on 28 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 February 2022
- Terminated
- 24 May 2022
- Reason
- A kit component, the PDI Prevantics Swab, was recalled.
- Distribution
- US distribution to two consignees located in Missouri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0950-2022
- Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Terminated Class II Medical devices
- Recall started
- 17 June 2020
- Terminated
- 29 July 2022
- Reason
- 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
- US Nationwide distribution including in the states of MO, NC, AR, OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2699-2020
- 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 c
Terminated Class II Medical devices
- Recall started
- 4 May 2020
- Terminated
- 23 September 2022
- Reason
- There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
- Distribution
- US Nationwide distribution including in the states of MO, NC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2369-2020, Z-2368-2020
- 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.