Device product
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Z-2540-2014
Product summary
- Event
- Event 68739
- Status
- Terminated
- Classification
- Class I
- Quantity
- 135,518 (110,246 nationwide)
- Official record key
device-enforcement:Z-2540-2014
Official wording
Reason: 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.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.