FDA-Device2014-09-03Class I
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Smiths Medical ASD, Inc.
Hazard
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
Sold states
Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
Affected count
135,518 (110,246 nationwide)
Manufactured in
10 Bowman Dr, N/A, Keene, NH, United States
Products
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2014Don't want to check this manually?
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