Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13189 |
| Brand Name: | Covidien Shiley Tracheostomy Tube, Cuffed with Inner Cannula |
| Model: | 8FEN |
| Affected: | Lots between 0910000342 and 1101001558; and 110201893x and 120600700x |
| Software version: | |
| Recalling Organisation: | Covidien NZ Ltd Level 3, Building 5, Central Park Corporate Centre 666 Great South Road Penrose AUCKLAND 1051 |
| Contact Information: | 0508 489 264 |
| Manufacturer: | Covidien LLC |
| Brand Name: | Covidien Shiley Tracheostomy Tube, Cuffed with Inner Cannula |
| Model: | 8LPC and 8LPC-S |
| Affected: | Lots between 0910000346 and 1101001823, and 110200327X and 120600351X (8LPC); 0910001002 and 1103002052, and 111000400X and 120600014X (8LOC-S) |
| Software version: | |
| Recalling Organisation: | Covidien NZ Ltd Level 3, Building 5, Central Park Corporate Centre 666 Great South Road Penrose AUCKLAND 1051 |
| Contact Information: | 0508 489 264 |
| Manufacturer: | Nellcor Puritan Bennett Inc |
| Issue: | The manufacturer has received reports of certain size 8 Shiley™ Reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. These events were typically observed during mechanical ventilation. If a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/7/2012 |
