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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion CirClamp

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  Class 2 Device Recall Centurion CirClamp see related information
Date Initiated by Firm March 02, 2023
Date Posted April 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1407-2023
Recall Event ID 91894
510(K)Number K890897  
Product Classification Clamp, circumcision - Product Code HFX
Product Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Code Information Lot #2022070590, Exp. 2026-08-31, UDI (01)10653160312895(10)2022070590(17)260831.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 The CirClamp subassembly found in the kit was the incorrect size.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated 3/2/2023 via first class mail informing the consignee of the issue and to remove it from stock and dispose of it. The letter provided required actions which again included destroying the affected product and to return the completed enclosed destruction form listing the quantity of affected product destroyed. Once the destruction form is received, the account will be issued a credit. If the device has been transferred to another individual, department or location, the consignee is to notify them of this recall communication.
Quantity in Commerce 162 units
Distribution US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HFX and Original Applicant = TRI-STATE HOSPITAL SUPPLY CORP.
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