FDA Device

Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K

Hazard

Catheter shaft has potential to crack during use.

What You Should Do

Remedy

On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.

Products

Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
Brand
Curon Medical Inc
UPC
FD1268 thru FD1282