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Closed Wound Suction

C. R. Bard, Inc. · Model 0090390 · UDI-DI 00801741050305

GCY Prescription

510(k) clearances

4,711

Adverse events (13 deaths)

107

Recalls

216

Facilities

Description

ReliaVac 100 Closed Wound Suction (CWS) Kit, 10mm Wide Hubless Silicone Flat Drain, 20cm Long, Fully Perforated, X-Ray Opaque, Low Suction, 100cc Evacuator, Y-Connecting Tube

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.