FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
- Recall number
- Z-2540-2014
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
- Status
- Terminated
- Initiated
- 2014-07-07
- Posted
- 2014-08-28
- Terminated
- 2021-05-26
- 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.
- Root cause
- Process change control
- Action
- 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.
- Quantity
- 135,518 (110,246 nationwide)
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28