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 2 Device Recall Arrow

  • 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 2 Device Recall Arrowsee related information
Date Initiated by FirmJune 17, 2009
Date PostedJuly 07, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall NumberZ-1653-2009
Recall Event ID 52388
510(K)NumberK862056 
Product Classification Central Venous Catheterization Set - Product Code DQY
ProductArrow 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 ContactJody 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
ActionArrow 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 Commerce3019 units
DistributionWorldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.
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 = DQY
-
-