BEUDAMED
    FDA Recall Terminated

    QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit

    Recall: Z-1357-2011 · Initiated October 29, 2010

    Recall

    Recall Number
    Z-1357-2011
    Event Number
    57287
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2010
    Posted
    February 17, 2011
    Terminated
    September 29, 2012
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF. Radial artery catheterization kit

    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.

    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.

    Quantity

    9,230 units