According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wire, guide, catheter - Product Code DQX
  • Reason
    Sterility may be compromised.
  • Action
    Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.


  • Model / Serial
    CC-04100 Lot Numbers: RF0019630, RF0035146, RF0062164, RF0063964, RF4121260, RF5012171, RF5022620, RF5022694, RF5022936, RF5023056, RF5043795, RF5044244, RF5054841, RF5060136, RF5072938, RF5083080, RF5084506, RF5095700, RF5106236, RF5118583, RF6012260, RF6022847, RF6033756, RF6034434, RF6035286, RF6057003, RF6068210, RF6070336, RF6080902, RF6081546, RF6093300, RF6104481, RF6115675, RF6116613, RF6127345, RF6127983, RF7018330, RF7020221, RF7032233, RF7054012, RF7054686, RF7065398, RF7076855, RF7077581, RF7088648, RF7089293, RF7090478, RF7101417, RF7112432, RF7113766, RF7124960, RF8015963, RF8020094, RF8029171, RF8031984, RF8033220, RF8044241, RF8045487, RF8056874, RF8057384, RF8068362, RF8071384, RF8083492, RF8085126, RF8096691, RF8109018, RF8110511, RF8110923, RF8123490, RF9015797, RF9027384, RF9028781, RF9030798, RF9044347, RF9056860, RF9057865, RF9060300, RF9071990, RF9101135, RF9112313, RF9112770, RF9114303 and RF9125231.  FS-04510 Lot Numbers: RF0020943, RF0033155, RF0059261, RF0062162, RF0075661, RF8033219, RF8045501, RF8070634, RF8119793, RF8124055, RF9030633, RF9068315, RF9071039, RF9085981, RF9101233 and RF9126921.  NS-04100 Lot Numbers: RF0021271, RF0035169, RF0059455, RF0062166, RF0076519, RF0087520, RF5012173, RF5012263, RF5022525, RF5022640, RF5022884, RF5033202, RF5043960, RF5044137, RF5044415, RF5054655, RF5055028, RF5060314, RF5072320, RF5084106, RF5095841, RF5106237, RF5107230, RF5118615, RF6011424, RF6012258, RF6022392, RF6033757, RF6034356, RF6045750, RF6057353, RF6057883, RF6068372, RF6068635, RF6070561, RF6079358, RF6080954, RF6081473, RF6082032, RF6093231, RF6104147, RF6116038, RF6116779, RF7018345, RF7020079, RF7029684, RF7031136, RF7031694, RF7042757, RF7043349, RF7054836, RF7066014, RF7066675, RF7077586, RF7088649, RF7089181, RF7090486, RF7101953, RF7102163, RF8015969, RF8016893, RF8029175, RF8031766, RF8033221, RF8044245, RF8045307, RF8057233, RF8068375, RF8072081, RF8083722, RF8097203, RF8107887, RF8111833, RF811833, RF9014775, RF9027307, RF9042699, RF9068374, RF9085995, RF9101133, RF9112853, RF9114302 and RF9125236.  PW-04100 Lot Numbers: RF8029429, RF8031774, RF8043868 and RF8057234.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.
  • Product Description
    ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100. || Cardiovascular catheterization kit
  • Manufacturer


  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source