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U.S. Department of Health and Human Services

Class 1 Device Recall TriState Centurion Implanted Access Port Tray

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 Class 1 Device Recall TriState Centurion Implanted Access Port Traysee related information
Date Initiated by FirmJanuary 14, 2009
Date PostedMarch 25, 2009
Recall Status1 Terminated 3 on December 31, 2009
Recall NumberZ-1167-2009
Recall Event ID 50867
Product Classification Procedure Tray - Product Code MCY
ProductTri-State Centurion Implanted Access Port Tray, sterile, 16 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder DT7105.
Code Information Lot 2008110650.
Recalling Firm/
Manufacturer
Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell MI 48843
For Additional Information Contact
517-546-5400 Ext. 1135
Manufacturer Reason
for Recall
Lack of assurance of sterility, as the package seals may be inadequate.
FDA Determined
Cause 2
Packaging process control
ActionTri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
Quantity in Commerce288
DistributionNationwide.
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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