Recall Z-2661-2014— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-09-04, terminated 2017-02-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-04
- Terminated
- 2017-02-22
- Firm location
- Research Triangle Park, NC, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.