Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom YelloPort Elite Universal Seal. For use in laparoscopic procedures. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

Recommended Action

Per FDA guidance

On June 2, 2022, Surgical Innovation issued a "urgent Field Safety Notice. On 6/8/2022, Surgical Innovations issued an "updated: Urgent Medical Device Recall notification via E-Mail to provide additional information and a revised recall strategy. The updated communication, ask consignees to take the following actions: 1.Identify the devices and quarantine all stock. 2. All product still in stock at end users must be returned to the distributor. 3. Confirmation that all such stock has been returned and that any other product has been successfully used must be obtained by the distributor. 4. The distributor shall inform Surgical Innovations of the quantities and an RMA will be provided by Surgical Innovations for return off the product to Surgical Innovations. 5. The devices shall then be returned to Surgical Innovations of disposition and the Distributor compensated for the carriage fees. 6. Replacement devices, as appropriate, which do not have this issue, will be provided by Surgical Innovations.