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U.S. Department of Health and Human Services

Class 2 Device Recall Arterial Catheterization Set

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  Class 2 Device Recall Arterial Catheterization Set 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-2494-2010
Recall Event ID 56363
510(K)Number K810675  
Product Classification Wire, Guide, Catheter - Product Code DQX
Product Arterial Catheterization Set
Code Information Product # CK-04018, Lot No's: RF0019104 and RF0022537
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 9
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 = DQX and Original Applicant = ARROW INTL., INC.