FDAFDA · Food and drugs·Recall number Z-2540-2014
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Published September 3, 2014 · Recall initiated: July 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- 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.
- Lot
- Lot Numbers: 2597332, 2585074, 2580798, 2576365, 2564404, 2564403, 2563088, 2549367, 2519413, 2500170, 2488207, 2474646, 2465828, 2453473, 2443378, 2438615, 2433450, 2412145, 2380351, 2376498, 2365494, 2365493, 2361580, 2357823, 2353347, 2343313, 2329583, 2326899, 2322825, 2298752, 2286594, 2278069, 2271358, 2263553, 2260562, 2260561, 2250053, 2250052, 2250050, 2250049, 2244749, 2228363, 2219213, 2211929, 2208194, 2191930, 2179229, 2175056, 2154534, 2142178, 2135983, 2128635, 2124241, 2120119, 2116099, 2090223, 2077179, 2063989, 2063988, 12040, 12033, 11877, 11876, 11874, 11873, 11679, 11655, 11407, 11405
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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