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U.S. Department of Health and Human Services

Class 2 Device Recall Teleflex MEDICAL WECK Visistat 35

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  Class 2 Device Recall Teleflex MEDICAL WECK Visistat 35 see related information
Date Initiated by Firm February 15, 2018
Create Date March 26, 2018
Recall Status1 Terminated 3 on October 31, 2018
Recall Number Z-1193-2018
Recall Event ID 79301
Product Classification Staple, removable (skin) - Product Code GDT
Product Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Code Information Lot Number 73H1600207
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact
847-572-8014
Manufacturer Reason
for Recall		 Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.
FDA Determined
Cause 2		 Packaging process control
Action The firm initiated the recall on 02/14/2018 by letter and followed up with another letter on 03/12/2018 to clarify the labeling issue. The letter to the distributor stated: "1. Immediately discontinue distribution and quarantine any products with the catalog and lot number listed above. 2. Inspect affected products within your control to identify if the box label correctly identifies the products inside the box. Products with an incorrect label on the box should be returned to Teleflex Medical so that they are not distributed to health care providers in error. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. Customers may return mislabeled products if they choose to do so. Note the attached Customer Letter template was updated since this letter was first sent to you. 4. If any of your customers wish to return affected products, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-246-6990." The customer letter requested discontinuation of use and quarantining of products and return of affected stock.
Quantity in Commerce 12 units
Distribution KS
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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