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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow

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  Class 2 Device Recall Arrow see related information
Date Initiated by Firm June 20, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on October 16, 2006
Recall Number Z-0030-2007
Recall Event ID 35959
Product Classification pressure catheter - Product Code NVM
Product Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
Code Information MF5124329
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Terrance M. Larkin
610-378-0131
Manufacturer Reason
for Recall		 The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
FDA Determined
Cause 2		 Other
Action Recall letter was sent to customers on 6/20/2006 by US mail.
Quantity in Commerce 11 units
Distribution Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
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.
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