Device Recall RUSCH

Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR).

Gastroenterology-Urology Devices

2

No

Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.

RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, || Intermittent self-catheterization

Lot/Batch Numbers 16A14 and 16A14

Anesthesiology Devices

1

No

Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and the countries of Canada and Mexico.

Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 || Product Usage: || To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.

Lot/Serial number: 1602312

Anesthesiology Devices

1

No

US only

Rusch(R) Greenlite MAC 1, Catalog Number 004551001

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.