FDAClass IIJune 24, 2020

Regard SRHS GIC Port A Cath recall

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…

Why was Regard SRHS GIC Port A Cath recalled?

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item number 303394REG: lot numbers: 259427, 262441, 264440, 268589, 268915, 271008, and 269694.

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…
Recalling firm
Resource Optimization & Innovation LLC
Quantity
9,360 units
Distribution
US Nationwide distribution including in the states of MO, NC.
Recall date
June 24, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls