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Exsudex disposable canister

Meditop B.V. · Model CCT Mini disposable canister with tube and luer-lock connector · UDI-DI 08718104890480

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

Description

The Exsudex® Disposable Canister, commercially labelled as CCT Mini Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube, 157.5 cm, with clamb and luer-lock connector - Dissolving sachet solidifying agent

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.