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Class 2 Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kit |
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Date Initiated by Firm |
March 01, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 24, 2008 |
Recall Number |
Z-0679-04 |
Recall Event ID |
28421 |
Product Classification |
Tubes, Gastrointestinal (And Accessories) - Product Code KNT
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Product |
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 18 Fr., 4.0 cm length, Item Numbers: 54260 and 55676. |
Code Information |
Lot Numbers: 12905GZ00, 83554GZ00, 84609GZ00, 87769GZ00, 88811GZ00, 89968GZ00, 91114GZ00, 92202GZ00, 93302GZ00, 01516GZ00, 10819GZ00, 82484GZ00, 86706GZ00, 89919GZ00, 92206GZ00, 94370GZ00. |
Recalling Firm/ Manufacturer |
Ross Products Division Abbott Laboratories 625 Cleveland Ave Columbus OH 43215-1754
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For Additional Information Contact |
614-624-3688
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Manufacturer Reason for Recall |
The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.
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FDA Determined Cause 2 |
Other |
Action |
The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned. |
Distribution |
Nationwide; Australia, New Zealand, Italy. |
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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