Date Initiated by Firm |
April 01, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on December 08, 2009 |
Recall Number |
Z-1907-2008 |
Recall Event ID |
47828 |
510(K)Number |
K960479
|
Product Classification |
Temporary pacemaker electrode - Product Code LDF
|
Product |
Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart. |
Code Information |
Part number: AI-07155-KS, Lot number RF8015919 (Distributed in the U.S.) |
Recalling Firm/ Manufacturer |
Arrow International Inc 312 Commerce Pl Asheboro NC 27203-0552
|
For Additional Information Contact |
Jody Cadd 610-378-0131
|
Manufacturer Reason for Recall |
The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
|
FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by letter on/about 04/11/ 2008. They were instructed to cease use and distribution, and quarantine all affected product. They were also instructed to complete an enclosed Acknowledgement & Stock Status Form and fax back to Arrow International. Consignees were further advised to communicate the recall notice to anyone who has received the affected product by providing a copy of the recall notice to their customer(s).
Contact Arrow International, Customer Relations Department at 800-523-8446 if you have questions. |
Quantity in Commerce |
686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally) |
Distribution |
U.S. South Africa, Venezuela |
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 = LDF and Original Applicant = ARROW INTL., INC.
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