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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Balloon Temporary Pacing Catheter Kit

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 Class 2 Recall
Arrow Balloon Temporary Pacing Catheter Kit
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on December 08, 2009
Recall Number Z-1907-2008
Recall Event ID 47828
Premarket Notification
510(K) Number
K960479 
Product Classification Electrode, Pacemaker, Temporary - 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, North Carolina 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LDF and Original Applicant = ARROW INTL., INC.
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