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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 Hemoloksee related information
Date Initiated by FirmSeptember 25, 2012
Date PostedOctober 18, 2012
Recall Status1 Terminated 3 on November 08, 2012
Recall NumberZ-0078-2013
Recall Event ID 63365
510(K)NumberK993157 
Product Classification Clip, implantable - Product Code FZP
ProductHem-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 ContactMichael 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
ActionTeleflex 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 Commerce126 units
DistributionNationwide Distribution including the state of Nevada.
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 = FZP
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