—#40461

Product

Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3

FDA product code: FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K010420
Affected lot / code info: product number RLA-142-3, lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02; the recall was expanded on 11/15/05 to include lot numbers 004622-3 and 004622-4

Why it was recalled

There is a lack of assurance of sterility for parts of these lots of product.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent their customers recall letters dated July 11, 2005 via UPS, 2 Day Delivery, on July 13, 2005. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Research Triangle Park, NC. Any questions were directed to Dan Daily at 1-800-334-9751, ext. 4029. The recall was extended to include the two additional lots by letter dated 11/15/05. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Durham, NC. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2005-07-11
Posted by FDA: 2005-08-04
Terminated: 2007-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40461. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.