Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Optical Trocars sterility assurance can not be guaranteed

Recommended Action

Per FDA guidance

On March 29, 2023, Surgical Innovations issued a "Urgent Field Safety Notice" to affected consignees via E-Mail. An update to the communication was sent on 4/17/2023 to affected consignees via E-Mail. In addition to informing consignees about the recall, Surgical Innovations ask consignees to take the following action: 1. Distributor should confirm receipt of this Field Safety Notice 2. Identify the devices held in stock at the distributor and quarantine affected batches awaiting further instruction. 3. Issue this Field Safety Notice to all end users (Hospital) that the distributor has supplied 4. All product still in stock at the end users must be returned to the distributor. 5. Confirmation must be obtained by the distributor that either all stock has been returned or that any other product has been successfully used. 6. Confirmation to Surgical Innovations using the attached form of this disposition of all stock 7. Await further instruction from Surgical Innovations regarding further action for the affected products.

Distribution

As reported by FDA

MA