Recall Z-0572-04 ยท BSR Stylet, Tracheal Tube
Smiths Medical ASD, Inc
Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
| Date | Jul 20, 2004 (initiated Jan 26, 2004) |
| Status | Terminated |
| Reason | Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr |
| Root cause | Other |
| Action | Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter. |
| Quantity | 46 cases (230 UNITS) |
| Distribution | CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902180 | TRACHEAL TUBE STYLET Sims Surgical, Inc., Jul 19, 1990 |