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U.S. Department of Health and Human Services

Class 2 Device Recall WECK Horizon

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  Class 2 Device Recall WECK Horizon see related information
Date Initiated by Firm August 24, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on August 25, 2017
Recall Number Z-2759-2016
Recall Event ID 75020
Product Classification Applier, surgical, clip - Product Code GDO
Product WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111,

Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.
Code Information Product Code: 337111, Lot Number: 06F1515745.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Michael T. Taggart
847-572-8014
Manufacturer Reason
for Recall		 Misbranded: Incorrect etching on the device.
FDA Determined
Cause 2		 Error in labeling
Action Teleflex sent an Urgent Medical Device Notification letter dated August 24, 2016 to customers via FedEx. The letter identified the affected product, problem and actions to be taken. For questionscontact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 49 units
Distribution Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.
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.
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