Device recall
Z-1213-2019: Procedure kits include devices from the affected lots distributed OUS only…
FDA device recall · Class II · COVIDIEN LLC
Key facts
| Recall number (Z-number) | Z-1213-2019 |
|---|---|
| Recall event | 82426 |
| Product | Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6)BOX PST01134 LAP CHOLE KIT ST… |
| Product code | HDA |
| Recalling firm | COVIDIEN LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2020 |
| 510(k) numbers | K903205 |
| FEI number | 1282497 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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