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U.S. Department of Health and Human Services

Class 3 Device Recall Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm

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  Class 3 Device Recall Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm see related information
Date Initiated by Firm September 16, 2003
Date Posted November 01, 2003
Recall Status1 Terminated 3 on April 05, 2004
Recall Number Z-0084-04
Recall Event ID 27415
510(K)Number K010399  
Product Classification Introducer, Syringe Needle - Product Code KZH
Product Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm
Code Information Catalog number CC-03600, Lot number RF3066991
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605
For Additional Information Contact Thomas D. Nickel
610-478-3137
Manufacturer Reason
for Recall
wrong product in box
FDA Determined
Cause 2
Other
Action The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.
Quantity in Commerce 34 units
Distribution The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.
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 = KZH and Original Applicant = DIATEK, INC.
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