Recall Z-2538-2014 ยท BTR Tube, Tracheal (W/Wo Connector)
Smiths Medical ASD, Inc.
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
| Date | Aug 28, 2014 (initiated Jul 7, 2014) |
| Status | Terminated |
| Reason | 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 | 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 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR Respiratory Support Products, Inc., Feb 21, 1979 |