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Terminated

Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

FDA Recall Z-2652-2010 · Posted 2010-09-30

Recalling FirmLumenis, Inc.
Recall StatusTerminated
Product CodeHQF
Date Initiated2010-07-27
Date Terminated2010-10-05
Product Quantity250 probes (25 boxes, each containing 10 probes)

Reason for Recall

Firm did not have proper 510(K) clearance.

Firm Action

Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.

Root Cause

Component change control

Distribution Pattern

FL, IL, MD, CO and TX

Official Source

View FDA Recall →

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

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