—#128585

Product

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

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K790312
Affected lot / code info: Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050

Why it was 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.

Root cause (FDA determination)

Process change control

Action the firm took

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 endotrachealtubeholders@smiths-medical.com. 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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

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.

Timeline

Recall initiated: 2014-07-07
Posted by FDA: 2014-08-28
Terminated: 2021-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.