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U.S. Department of Health and Human Services

Class 3 Device Recall Centurion

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 Class 3 Device Recall Centurionsee related information
Date Initiated by FirmApril 12, 2005
Date PostedMay 12, 2005
Recall Status1 Terminated 3 on September 08, 2005
Recall NumberZ-0837-05
Recall Event ID 31645
510(K)NumberK890897 
Product Classification Clamp, Circumcision - Product Code HFX
ProductCenturion brand CirClamp with 1.1 cm bell, sterile, single use; product 310.
Code Information Lot 11224.
Recalling Firm/
Manufacturer		 Tri-State Hospital Supply Corp
301 Catrell Dr
Howell MI 48843-1703
For Additional Information ContactKaren Kowalczyk
517-546-5400 Ext. 1122
Manufacturer Reason
for Recall		Not labeled as reprocessed, when this lot has been reprocessed.
FDA Determined
Cause 2		Other
ActionConsignees were notified to return the product via letter dated 4/12/05.
Quantity in Commerce1572
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.
510(K) Database510(K)s with Product Code = HFX
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