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BAROVAC® Evacuator Closed Wound Drainage System(SS)

Sewoon Medical Co., Ltd. · Model SS200L+(4.8) · UDI-DI 08806369453066

GCY

510(k) clearances

4,706

Adverse events (13 deaths)

107

Recalls

215

Facilities

Recalls

Date	Firm	Reason
2018-11-05	COVIDIEN LLC	The product was released into commercial distribution while subject to importation refusal.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
2017-04-21	Cardinal Health 200, LLC	Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

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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.