—#102356

Product

RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K896729
Affected lot / code info: Product number: 238300140, Lot numbers: 12011, 102728, 105236, 105237, 106237, 106300, 111799, 116422, 117536, 117537, 118157, 118757, 118758, 119911, 121011, 122270, 122279, 122279-1, 134622, 135867, 138384, 140684, 142580, 142581, 142689, 145829, 242221, 310437, 318009, 322171, 325864, 335519, 338391, 340217, 342051, 342052, 350060, 350061, 350062, 351724, 355195, 358832, 359276, 359277, 359992, 378594, 378595, 378596, 379601, 380257, 380258, 380259, 380290, 381735, 384505 and 405525.

Why it was recalled

Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Worldwide Distribution and (USA) Nationwide Distribution.

Timeline

Recall initiated: 2011-06-30
Posted by FDA: 2011-08-03
Terminated: 2014-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.