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Terminated

Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

FDA Recall Z-1756-2010 · Posted 2010-06-04

Recalling FirmKim's Trading Inc
Recall StatusTerminated
Product CodeLPM
Date Initiated2010-05-17
Date Terminated2010-08-11
Product Quantity300 pairs of contact lens

Reason for Recall

Recall is being conducted because the recalled color cosmetic contact lenses are unapproved medical devices.

Firm Action

Kim's Trading Inc. verbally contacted the distributor to provide notification of the recall. All affected product was to be properly disposed. For further information, contact Kim's Trading Inc. at 1-484-895-3773.

Root Cause

PMA

Distribution Pattern

All product was distributed to one distributor in the Bethlehem PA area.

Official Source

View FDA Recall →

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

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