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SEDASYS
ETHICON ENDO-SURGERY, INC. · Model SEDPSU01 · UDI-DI 10705036010210
PDR
Prescription
0
510(k) clearances
13
Adverse events
1
Recalls
0
Facilities
Description
SEDASYS POWER SUPPLY UNIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-05-13 | Ethicon Endo-Surgery Inc | Ethicon 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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Get your free API keyRead the docsData 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.