Recall Z-1193-2018 ยท GDT Staple, Removable (Skin)
Teleflex Medical
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
| Date | Feb 15, 2018 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 12 units |
| Distribution | KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.