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U.S. Department of Health and Human Services

Class 1 Device Recall MAC (TM) Two Lumen Central Venous Access Kit with ARROWgard Blue (R) Access Device,

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 Class 1 Device Recall MAC (TM) Two Lumen Central Venous Access Kit with ARROWgard Blue (R) Access Device,see related information
Date Initiated by FirmNovember 24, 2009
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on January 18, 2012
Recall NumberZ-0783-2010
Recall Event ID 53954
510(K)NumberK011761 
Product Classification Introducer, catheter - Product Code DYB
ProductMAC (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)
Code Information Product number ASK-21242-UVA2. Lot numbers RF9068459 and RF9060775
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information ContactCustomer Service Department
800-523-8446
Manufacturer Reason
for Recall		Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce117 kits
DistributionThe products were shipped to distributors in GA, MD, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DYB
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