RecallRadar

FDA Device recall Z-2537-2014

H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

On 2014-09-03 the FDA classified a Class I recall of H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit by Smiths Medical Asd, citing 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 s….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2537-2014
ClassificationClass I
Statusterminated
Initiated2014-07-07
Published2014-09-03
Last updated2026-09-13 11:53 UTC
CompanySmiths Medical Asd
DistributionAK, 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

Product

H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

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.

Identifiers

code_info
Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733…Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179, 2191911, 2188447, 2179221, 2175047, 2154527, 2152029, 2142174, 2128628, 2119944, 2109010, 2099495, 2090213, 2068117, 2063968, 2063967, 2042403, 12049, 12047, 12044, 11669, 11403

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2014%22

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