(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information: (1) Lot Number: 13F17D0179; (2) Lot Numbers: 13F17B0232, 13F17C0357, 13F17D0312, 13F17E0289, 13F17F0154, 13F17F0327, 13F17F0614

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.