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U.S. Department of Health and Human Services

Class 2 Device Recall Gastrointestinal tube

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  Class 2 Device Recall Gastrointestinal tube see related information
Date Initiated by Firm November 14, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-0189-04
Recall Event ID 27691
510(K)Number k861323  
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
Product Ross 22 FR Gastrostomy Tube, Item #156.
Code Information Lot Numbers: 01523GZ00, 04654GZ00, 93288GZ00, 95423GZ00
Recalling Firm/
Manufacturer		 Ross Products Division, Abbott Laboratories
625 Cleveland Ave
Columbus OH 43215-1754
For Additional Information Contact Mr. Randal P. McKay
614-624-3688
Manufacturer Reason
for Recall		 An increase in reported balloon failures, which may result in tube displacement.
FDA Determined
Cause 2		 Other
Action The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
Distribution Nationwide. Worldwide.
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.
510(K) Database 510(K)s with Product Code = KNT and Original Applicant = MICROVASIVE
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