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U.S. Department of Health and Human Services

Class 2 Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kit

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 Class 2 Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kitsee related information
Date Initiated by FirmMarch 01, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 24, 2008
Recall NumberZ-0685-04
Recall Event ID 28421
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
ProductRoss Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.7 cm length, Item Numbers: 54194 and 55688.
Code Information Lot Numbers: 01496GZ00, 10807GZ00, 84606GZ00, 84613GZ00, 86744GZ00, 89891GZ00, 90038GZ00, 91082GZ00, 93265GZ00, 96436GZ00, 96474GZ00.
FEI Number 1000136098
Recalling Firm/
Manufacturer		 Ross Products Division Abbott Laboratories
625 Cleveland Ave
Columbus OH 43215-1754
For Additional Information Contact
614-624-3688
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.
FDA Determined
Cause 2		Other
ActionThe firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.
DistributionNationwide; Australia, New Zealand, Italy.
Total Product Life CycleTPLC 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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