Device Recall RUSCH

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

Gastroenterology-Urology Devices

2

No

Nationwide

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

Catalogue number: 390060, Lot number: 20100515 & 20100501; Catalogue number: 452919, Lot number: 20100405.

Gastroenterology-Urology Devices

1

No

Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.

RUSCH Urinary Drainage Bag, 2000 ml || Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.

Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.

Gastroenterology-Urology Devices

1

No

Nationwide Distribution (USA) including the states of FL, GA, OH and SC.

Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. || Used for urine collection.

Product number: 238500220, Lot numbers: 108305, 140250, 142683, 153802, 276286, 359988, 370083, 375047 and 378586.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution and (USA) Nationwide Distribution.

RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 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.

Product Number: 238300080, Lot Numbers: 082827-1, 120007, 122274, 122275, 123171, 124446, 129582, 130627, 142572, 318007, 322167, 335514,338383, 340211, 342044, 350053, 350054, 350055, 359272, 359989 and 405523.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution and (USA) Nationwide Distribution.

RUSCH, GB: Female Catheter, All Purpose PVC, 08 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.