Class 2 Device Recall CENTRAL VENOUS CATHETERIZATION KIT

• Date Initiated by Firm: October 29, 2010
• Date Posted: February 17, 2011
• Recall Status: Terminated on September 29, 2012
• Recall Number: Z-1348-2011
• Recall Event ID: 57287
• 510(K)Number: K820009
• Product Classification: Catheter, percutaneous - Product Code DQY
• Product: CENTRAL VENOUS CATHETERIZATION KIT/Product SKU's (Codes) AK-04650-E and AK-04660. Central venous catheterization kit
• Code Information: AK-4650-E Lot Numbers: RF0019520, RF0021354, RF0046482, RF0046961, RF0063424, RF5117904, RF6022525, RF6023560, RF6023566, RF6045757, RF6057357, RF6079772, RF6092792, RF6104795, RF6105161, RF6127332, RF6127674, RF7018942, RF7031005, RF7031998, RF7054159, RF7077028, RF7090472, RF7091001, RF7112897, RF7124307, RF8016370, RF8020798, RF8029139, RF8045217, RF8056796, RF8058001, RF8071697, RF8072284, RF8083910, RF8095863, RF8108791, RF8110833, RF9016136, RF9044809, RF9072425, RF9083735, RF9085743 and RF9113835. AK-4660 Lot Numbers: RF0034148, RF0046483, RF0061650, RF0063020, RF0075819, RF0087771, RF5117911, RF5129632, RF6023024, RF6057559, RF6092439, RF6104845, RF7018862, RF7032229, RF7054430, RF7077080, RF7089171, RF7102397, RF8016283, RF8029410, RF8033120, RF8045315, RF8057243, RF8058270, RF8083403, RF8097345, RF8122721, RF9044663, RF9055442, RF9084406, RF9097333 and RF9114824.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: Ms. Jody Cadd; 610-378-0131 Ext. 3318
• Manufacturer Reason for Recall: Sterility may be compromised.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 40,260
• 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.
• 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