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U.S. Department of Health and Human Services

Class 2 Device Recall Hemolok

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  Class 2 Device Recall Hemolok see related information
Date Initiated by Firm September 25, 2012
Date Posted October 18, 2012
Recall Status1 Terminated 3 on November 08, 2012
Recall Number Z-0078-2013
Recall Event ID 63365
510(K)Number K993157  
Product Classification Clip, implantable - Product Code FZP
Product Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709.

Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.
Code Information Catalog No. 544240, Lot #01E1200585
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
FDA Determined
Cause 2		 Packaging process control
Action Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical. We sincerely apologize for any inconvenience this action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 126 units
Distribution Nationwide Distribution including the state of Nevada.
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 = FZP and Original Applicant = WECK CLOSURE SYSTEMS
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