Z-2536-2014Class I

4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

Name: Z-2536-2014 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Creator: Smiths Medical ASD, Inc.
Published: 2014-07-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-07-07 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit on 2014-07-07. FDA classified it as Class I and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2536-2014
Classification: Class I
Status: Terminated
Initiated: 2014-07-07
Posted: 2014-08-28
Terminated: 2021-05-26
Recalling firm: Abbott Medical
Product: 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Product code: BTR Tube, Tracheal (W/Wo Connector)
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.
FDA root cause: Process change control
Action: Smiths Medical sent an Urgent Medical Device Recall Notice dated July 11, 2014, to all affected customers. The letter informed customers of the recall and instructed them to inspect their inventory and segregate any unused affected products and to complete and return the Recall Confirmation Form, by Fax 1-800-621-2590 or email to [email protected]. Customers with questions were instructed to call Smiths Medical's Customer Service Department at 1-800-258-5361. For questions regarading this recall call 866-216-8806.
Quantity in commerce: 135,518 (110,246 nationwide)
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, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
Product codes and lots: Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2536-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2536-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2537-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2538-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2539-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2540-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28
Z-2541-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-28

Product code BTR

K790312Class IIEndotracheal Tube W/holder & ConnectorRespiratory Support Products, Inc. / cleared 1979-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)