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Silicone Reservoir 200 ml

REDAX SPA · Model 10410 · UDI-DI 08034139290638

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

Description

The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors for connection to the drainage tube. The reservoir has a capacity of 200 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full.

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.