—#161845

Product

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

FDA product code: GDT — Staple, Removable (Skin)
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number 73H1600207

Why it was recalled

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: KS

Timeline

Recall initiated: 2018-02-15
Terminated: 2018-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.