FDA Device Intelligence
Home › MCKESSON MEDICAL-SURGICAL INC. › McKesson

McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model 19-322160 · UDI-DI 00612479177871

GCY Prescription
10
510(k) clearances
4,734
Adverse events (13 deaths)
107
Recalls
219
Facilities

Description

Silicone Bulb Evacuator 100mL

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.