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HomeASPEN SURGICAL PRODUCTS, INC. › S-Vac® Fluted Channel Drain

S-Vac® Fluted Channel Drain

ASPEN SURGICAL PRODUCTS, INC. · Model 322227 · UDI-DI 00840113200085

GCY
10
510(k) clearances
4,706
Adverse events (13 deaths)
107
Recalls
215
Facilities

Description

Intended used for closed wound suction drainage

Recalls

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