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Sertilac

PETERS SURGICAL · Model 32300M20 · UDI-DI 03661522000984

GAE
4
510(k) clearances
150
Adverse events
3
Recalls
67
Facilities

Recalls

DateFirmReason
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
2008-05-09Bard Peripheral Vascular IncThis action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign bod
2008-05-09Bard Peripheral Vascular IncThis action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign bod

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.