FDA Device

MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Hazard

Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.

What You Should Do

Remedy

The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446.

Products

MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters
Brand
Arrow International Inc
UPC
Product number ASK-21242-UVA2. Lot numbers RF9068459 and RF9060775

Units Affected

117 kits