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Terminated

REGARD Vitrectomy Tray

FDA Recall Z-0256-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeOJK
Date Initiated2021-08-10
Date Terminated2023-06-16
Product Quantity22 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.

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