Recall Z-2661-2014 ยท KOD Catheter, Urological
Teleflex Medical
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
| Date | Sep 18, 2014 (initiated Sep 4, 2014) |
| Status | Terminated |
| Reason | Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label. |
| Root cause | Labeling Change Control |
| Action | Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015. |
| Quantity | 193,363 ea. + 1,140 units (total 194,503 units) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.