Device recall
Z-1357-2023: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless…
FDA device recall · Class I · Covidien
Key facts
| Recall number (Z-number) | Z-1357-2023 |
|---|---|
| Recall event | 91943 |
| Product | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1; 10UN10H, 10.0MM SHILEY… |
| Product code | JOH |
| Recalling firm | Covidien |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K142296, K150844 |
| FEI number | 2936999 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database