FDA recall Z-2368-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-05-04

Report date

2020-06-24

Termination date

2022-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2368-2020