Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the rout

FDA device recall Z-2661-2014 · posted 2014-09-18 · Terminated

Recall details

Recalling firm

Teleflex Medical

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.

Action taken

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

Status

Terminated

Product code

KOD

Quantity affected

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, I

Date initiated

2014-09-04

Date posted

2014-09-18

Date terminated

2017-02-22

Location

Research Triangle Park, NC