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Class 2 Device Recall ACAT 1 Series |
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Date Initiated by Firm |
November 12, 2007 |
Date Posted |
January 25, 2008 |
Recall Status1 |
Terminated 3 on January 11, 2010 |
Recall Number |
Z-0549-2008 |
Recall Event ID |
45871 |
510(K)Number |
K965209
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Product Classification |
Intra-Aortic Balloon and Control System - Product Code DSP
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Product |
ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149 |
Code Information |
SERIAL NOS: 070511A, 070512A, 070513A, 070514A, 070515A, 070516A, 070517A, 070518A, 070519A, 070520A, 070521A, 070522A, 070523A, 070524A, 070525A, 070601A, 070602A, 070603A, 070604A, 070605A, 10708A, 70206A, 70207A, 70208A, 70209A, 70210A, 70301A, 70302A, 70303A, 70304A, 70305A, 70401A, 70402A, 70403A, 70404A, 70405A, 70501A, 70502A, 70503A, 70504A, 70505A, 70506A, 70507A, 70508A, 70509A, 70510A, and 90305A |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact |
Mike Neibert, Director Global Tech Servi 800-447-4227
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Manufacturer Reason for Recall |
Leak may occur in the helium drive system for the IABP
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FDA Determined Cause 2 |
Material/Component Contamination |
Action |
Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative. |
Quantity in Commerce |
47 units |
Distribution |
Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey. |
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 = DSP and Original Applicant = ARROW INTL., INC.
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