Smiths Medical ASD, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2541-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit

Product Classification:

Class I

Date Initiated: July 7, 2014

Date Posted: September 3, 2014

Recall Number: Z-2541-2014

Event ID: 68739

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.

Status: Terminated

Product Quantity: 135,518 (110,246 nationwide)

Code Information:

Lot Numbers: 2602399, 2588625, 2580799, 2576366, 2523679, 2513119, 2492246, 2481855, 2474647, 2465829, 2457754, 2443379, 2438616, 2433451, 2428215, 2412146, 2394061, 2380352, 2376566, 2365454, 2361579, 2357822, 2347642, 2343312, 2343311, 2329584, 2322827, 2309473, 2298755, 2298754, 2286596, 2271359, 2250054, 2244752, 2244751, 2228364, 2211930, 2208196, 2191931, 2188460, 2179231, 2175057, 2154535, 2152054, 2146301, 2142179, 2135984, 2128636, 2120121, 2116100, 2109019, 2090224, 2077180, 2068123, 2063991, 2063990, 11889, 11870, 11859, 11697, 11695, 11694, 11657, 11654, 11406

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.

Voluntary or Mandated:

Voluntary: Firm initiated