Food, drugs, devices › Smiths Medical ASD, Inc.
Device recall: 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Smiths Medical ASD, Inc. (Keene, NH) initiated this device recall on 7 Jul 2014; FDA lists 6 product records under event 68739, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 5% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 26 May 2021. Initiation: voluntary: firm initiated. Smiths Medical ASD, Inc. has 108 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smiths Medical ASD, Inc., Keene, NH.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2536-2014 | 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
| Z-2537-2014 | H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
| Z-2538-2014 | H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
| Z-2539-2014 | H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
| Z-2540-2014 | H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
| Z-2541-2014 | H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit | 135,518 (110,246 nationwide) | Class I | Terminated | 3 Sep 2014 |
Context
Other enforcement events for Smiths Medical ASD, Inc.
All 108 events for Smiths Medical ASD, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.