CLASS I Device recall · Reported 3 Sep 2014 · FDA Enforcement Report
4001PS Neonatal/Paed.Intubation Kit Murphy recalled
Smiths Medical ASD is recalling 4001PS Neonatal/Paed.Intubation Kit Murphy, LDS Conn Pediatric Endotracheal Intubation Kit, distributed in 41 states. The recall was initiated on 7 Jul 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2536-2014
- FDA event ID
- 68739
- Recalling firm
- Smiths Medical ASD, Keene, NH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Jul 2014
- FDA classified
- 28 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jul 2014 | Recall initiated by company | |
| 28 Aug 2014 | Classified by FDA | +52 days |
| 3 Sep 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Where it was distributed
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.
AlaskaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 68739This product is part of a recall event; the main page for the event is H4051 Endo Tube Holder, Pedi Pediatric Endotracheal Intubation Kit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | H4051 Endo Tube Holder, Pedi Pediatric Endotracheal Intubation Kit recalled | Smiths Medical ASD | Other | 41 states | |
| CLASS I | H4052 Endo Tube Holder, Pedi Pediatric Endotracheal Intubation Kit recalled | Smiths Medical ASD | Other | 41 states | |
| CLASS I | H4002S Neonatal/Paed.Intubation Kit Murphy Conn recalled | Smiths Medical ASD | Other | 41 states | |
| CLASS I | H4002PS Neonatal/Paed.Intubation Kit Murphy recalled | Smiths Medical ASD | Other | 41 states | |
| CLASS I | H4001S Neonatal/Paed.Intubation Kit Murphy Conn recalled | Smiths Medical ASD | Other | 41 states |
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