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Recall Observatory FDA recall evidence

Device product

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

Z-2541-2014

July 07, 2014

Class I

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 68739
Status
Terminated
Classification
Class I
Quantity
135,518 (110,246 nationwide)
Official record key
device-enforcement:Z-2541-2014

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: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.