Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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,

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall MAC (TM) Two Lumen Central Venous Access Kit with ARROWgard Blue (R) Access Device, see related information
Date Initiated by Firm November 24, 2009
Date Posted March 05, 2010
Recall Status1 Terminated 3 on January 18, 2012
Recall Number Z-0783-2010
Recall Event ID 53954
510(K)Number K011761  
Product Classification Introducer, catheter - Product Code DYB
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)
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 Contact Customer 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
Action 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.
Quantity in Commerce 117 kits
Distribution The products were shipped to distributors in GA, MD, and VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DYB and Original Applicant = ARROW INTL., INC.
-
-