Resource Optimization & Innovation LLC: Medical Device Recall in 2020 - (Recall #: Z-2369-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: May 4, 2020
Date Posted: June 24, 2020
Recall Number: Z-2369-2020
Event ID: 85632
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.

Status: Terminated
Product Quantity: 12,640 units
Code Information:

Item number 303399REG: lot numbers: 257967, 259035, 260742, 259418, 261252, 261888, 263836, 264669, 268918, 271005, 265730, 270198, and 270567.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated