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AMSure® Bubble Connecting Tube

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411001027

BYY Prescription
10
510(k) clearances
216
Adverse events (2 deaths)
6
Recalls
170
Facilities

Description

AMSure® Bubble Connecting Tube 1/4" I. D. (6.4 mm) Bulk, Non-sterile 100' (30.5 m)/Case

Recalls

DateFirmReason
2025-01-15DeRoyal Industries IncThe tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay i
2008-04-21Mentor Texas, IncDuring packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
2003-11-07Vital Concepts, Inc.The probe may separate from the cannula.
2003-11-07Vital Concepts, Inc.The probe may separate from the cannula.
2003-11-07Vital Concepts, Inc.The probe may separate from the cannula.
2003-11-07Vital Concepts, Inc.The probe may separate from the cannula.

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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.