| Class 2 Device Recall HideAPort Low Profile Balloon Gastrostomy Tube Kit | |
Date Initiated by Firm | March 01, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on October 24, 2008 |
Recall Number | Z-0703-04 |
Recall Event ID |
28421 |
Product Classification |
Tubes, Gastrointestinal (And Accessories) - Product Code KNT
|
Product | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm length, Item Numbers: 54230
and 55725. |
Code Information |
Lot Numbers: 03620GZ00, 83545GZ00, 85651GZ00, 87789GZ00, 89926GZ00, 92196GZ00, 92221GZ00, 85636GZ00, 89896GZ00, 91138GZ00. |
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 |
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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