—#129815

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.

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-09-04
Posted by FDA: 2014-09-18
Terminated: 2017-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.