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/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact |
Walter C. Henry 610-478-3159
|
Manufacturer Reason for Recall |
package lid identifies the contents incorrectly
|
FDA Determined Cause 2 |
Other |
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.
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