Recall Z-2661-2014
Teleflex Medical · initiated September 4, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.
Reason for recall
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
FDA-determined cause: Labeling Change Control
Action taken
Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015.
Details
- Recall number
- Z-2661-2014
- Initiated
- September 4, 2014
- Posted by FDA
- September 18, 2014
- Terminated
- February 22, 2017
- Product code
- KOD – Catheter, Urological
- 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, Switzerland, Turkey, Portugal and Zambia.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC