Quanta System Sterile Optical Laser Fiber, single use
FDA Recall Z-1843-2021 · Posted None
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Recalling FirmQuanta System, S.p.A.
Recall StatusTerminated
Product CodeGEX
Date Initiated2021-04-27
Date Terminated2023-09-05
Product Quantity2427 units
Reason for Recall
Product sterility is potentially compromised.
Firm Action
The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form.
Root Cause
Process control
Distribution Pattern
Nationwide distribution via 6 US distributors
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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