FDA-Device2014-12-31Class I
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Halyard Health
Hazard
The cuff inflation line may detach from the endotracheal tube during use.
Sold states
Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
Affected count
430 cases (10 tubes per case)
Manufactured in
1400 Holcomb Bridge Rd, Roswell, GA, United States
Products
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0866-2015Don't want to check this manually?
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