PlainRecalls
FDA Devices Moderate Class II Terminated

REGARD Core Biopsy Tray

Reported: November 24, 2021 Initiated: August 10, 2021 #Z-0251-2022

Product Description

REGARD Core Biopsy Tray

Reason for Recall

Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

Details

Recalling Firm
ROi CPS LLC
Units Affected
1,200 trays
Distribution
US Nationwide in the states of FL, LA and MO.
Location
Republic, MO

Frequently Asked Questions

What product was recalled?
REGARD Core Biopsy Tray. Recalled by ROi CPS LLC. Units affected: 1,200 trays.
Why was this product recalled?
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0251-2022.