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U.S. Department of Health and Human Services

Class 2 Device Recall MAC Two Lumen Central Venous Access

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  Class 2 Device Recall MAC Two Lumen Central Venous Access see related information
Date Initiated by Firm July 29, 2010
Date Posted September 25, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-2488-2010
Recall Event ID 56363
510(K)Number K002507  
Product Classification Introducer, Catheter - Product Code DYB
Product MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Code Information Product # AK-11142-B, Lot # RF0033311
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Christine Richards
Manufacturer Reason
for Recall
Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
FDA Determined
Cause 2
Mixed-up of materials/components
Action The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
Quantity in Commerce 16
Distribution The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
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.