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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow

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  Class 2 Device Recall Arrow see related information
Date Initiated by Firm June 17, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall Number Z-1653-2009
Recall Event ID 52388
510(K)Number K862056  
Product Classification Central Venous Catheterization Set - Product Code DQY
Product Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
Code Information Catalog number: CS-14502, Lot numbers: RF7019488 and RF7029944.
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Jody Cadd
610-378-0131
Manufacturer Reason
for Recall		 The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.
FDA Determined
Cause 2		 Process design
Action Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.
Quantity in Commerce 3019 units
Distribution Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
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 = DQY and Original Applicant = ARROW INTL., INC.
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