Device recall
Z-1144-03: Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red…
FDA device recall · Class III · C.R. Bard, Inc., Urological Division
Key facts
| Recall number (Z-number) | Z-1144-03 |
|---|---|
| Recall event | 26828 |
| Product | Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter… |
| Product code | MJC |
| Recalling firm | C.R. Bard, Inc., Urological Division |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 19, 2003 |
| 510(k) numbers | K984136 |
| FEI number | 1018233 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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