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 Recall Z-2661-2014 · Posted 2014-09-18
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeKOD
Date Initiated2014-09-04
Date Terminated2017-02-22
Product Quantity193,363 ea. + 1,140 units (total 194,503 units)
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.
Firm Action
Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015.
Root Cause
Labeling Change Control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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