Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

REGARD Ear Tray

FDA Recall Z-0252-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeOGR
Date Initiated2021-08-10
Date Terminated2023-06-16
Product Quantity44 trays

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.

Firm Action

The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑