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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 tubesee related information
Date Initiated by FirmNovember 14, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 24, 2008
Recall NumberZ-0187-04
Recall Event ID 27691
510(K)NumberK861323 
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
ProductRoss 18 FR Gastrostomy Tube, Item #154.
Code Information 01502GZ00, 04632GZ00, 05667GZ00, 05686GZ00, 89877GZ00, 90981GZ00, 91104GZ00, 92182GZ00, 92213GZ00, 95409GZ00
FEI Number 1000136098
Recalling Firm/
Manufacturer		 Ross Products Division, Abbott Laboratories
625 Cleveland Ave
Columbus OH 43215-1754
For Additional Information ContactMr. 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
ActionThe firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
DistributionNationwide. Worldwide.
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.
510(K) Database510(K)s with Product Code = KNT
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