H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Recall Z-2537-2014 · Posted 2014-08-28
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBTR
Date Initiated2014-07-07
Date Terminated2021-05-26
Product Quantity135,518 (110,246 nationwide)
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.
Firm 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.
Root Cause
Process change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.