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U.S. Department of Health and Human Services

Class 3 Device Recall 10 FR Super ArrowFlex Percutaneous Sheath Introducer Set

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  Class 3 Device Recall 10 FR Super ArrowFlex Percutaneous Sheath Introducer Set see related information
Date Initiated by Firm October 22, 2003
Date Posted November 01, 2003
Recall Status1 Terminated 3 on April 05, 2004
Recall Number Z-0088-04
Recall Event ID 27540
510(K)Number K924607  
Product Classification Introducer, Syringe Needle - Product Code KZH
Product 10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
Code Information Catalog/Model number CL-07011, Lot number CF03075226
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Walter C. Henry
Manufacturer Reason
for Recall
package lid identifies the contents incorrectly
FDA Determined
Cause 2
Action The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.
Quantity in Commerce 80 units
Distribution The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka
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 = ARROW INTL., INC.