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SEDASYS

ETHICON ENDO-SURGERY, INC. · Model SED8UC · UDI-DI 20705036003554

PDR Prescription
0
510(k) clearances
13
Adverse events
1
Recalls
0
Facilities

Description

SEDASYS UMBILICAL CABLE

Recalls

DateFirmReason
2015-05-13Ethicon Endo-Surgery IncEthicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.