Device recall
Z-0562-04: BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological…
FDA device recall · Class III · C.R. Bard, Inc., Urological Division
Key facts
| Recall number (Z-number) | Z-0562-04 |
|---|---|
| Recall event | 28310 |
| Product | BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled… |
| Product code | KOD |
| Recalling firm | C.R. Bard, Inc., Urological Division |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 9, 2004 |
| FEI number | 1018233 |
At a glance
- None 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