A.R.C. Laser Photolysis Probe/Handpiece
FDA Recall Z-0981-03 · Posted 2003-07-03
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Recalling FirmA.R.C. Laser Corp
Recall StatusTerminated
Product CodeGEX
Date Initiated2003-06-06
Date Terminated2003-07-23
Product Quantity370 units
Reason for Recall
Product may not have been properly sterilized.
Firm Action
The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
Root Cause
Other
Distribution Pattern
IN, NY, PA, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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