H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
This recall has been terminated (originally issued August 28, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- July 7, 2014
- Posted
- August 28, 2014
- Terminated
- May 26, 2021
- Recall Number
- Z-2540-2014
- Quantity
- 135,518 (110,246 nationwide)
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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 / Code Info
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
Root Cause
Process change control
Action Taken
Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to endotrachealtubeholders@smiths-medical.com. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.