Recall Z-1732-2019 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
| Date | Feb 11, 2019 |
| Status | Terminated |
| Reason | Packaged with an incorrect size inner cannula. |
| Root cause | Error in labeling |
| Action | During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included wit |
| Quantity | 7,840 |
| Distribution | Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA Portex , Ltd., Aug 27, 2003 |