—#86931

Product

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)

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011761
Affected lot / code info: Product number ASK-21242-UVA2. Lot numbers RF9068459 and RF9060775

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: The products were shipped to distributors in GA, MD, and VA.

Timeline

Recall initiated: 2009-11-24
Posted by FDA: 2010-03-05
Terminated: 2012-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86931. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.