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Class 3 Device Recall Arrow Howes multilumen central venous catheterization kit 7 Fr x 20 cm |
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Date Initiated by Firm |
September 16, 2003 |
Date Posted |
November 01, 2003 |
Recall Status1 |
Terminated 3 on April 05, 2004 |
Recall Number |
Z-0082-04 |
Recall Event ID |
27415 |
510(K)Number |
K900263
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Product Classification |
Introducer, Syringe Needle - Product Code KZH
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Product |
Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm |
Code Information |
Catalog number AK-25703, Lot number RF3066892 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605
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For Additional Information Contact |
Thomas D. Nickel 610-478-3137
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Manufacturer Reason for Recall |
wrong product in box
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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 |
4480 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
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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.
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510(K) Database |
510(K)s with Product Code = KZH and Original Applicant = ARROW INTL., INC.
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