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Class 2 Device Recall Arrow |
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Date Initiated by Firm |
September 29, 2006 |
Date Posted |
December 19, 2006 |
Recall Status1 |
Terminated 3 on June 04, 2007 |
Recall Number |
Z-0287-2007 |
Recall Event ID |
36522 |
510(K)Number |
K921475 K882230
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Product Classification |
Implantable Vascular Access System - Product Code LJT
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Product |
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port. Ref Product No. AP-01510 |
Code Information |
Product No. AP-01510. Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869, MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233, MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651, MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739, MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605, MS4041616, MS4041617,MS4041618. |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact |
Paul Cornelison 610-378-0131
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Manufacturer Reason for Recall |
Catheter has separated from the infusion port body.
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FDA Determined Cause 2 |
Other |
Action |
The recall notification was sent out to their US customers on 9/29/2006. |
Quantity in Commerce |
204 |
Distribution |
Nationwide. The firm is NOT recalling from international accounts. |
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 = LJT and Original Applicant = THEREX CORP.
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