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Terminated

CIRCUMCISION TRAY

FDA Recall Z-1082-2018 · Posted None

Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeLRP
Date Initiated2017-10-23
Date Terminated2018-06-21

Reason for Recall

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Firm Action

On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationally

Official Source

View FDA Recall →

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

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