FDA recall Z-0256-2022

Product

REGARD Vitrectomy 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.

Distribution

US Nationwide in the states of FL, LA and MO.

Key facts

Status

Terminated

Initiation date

2021-08-10

Report date

2021-11-24

Termination date

2023-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0256-2022