Recall Z-1396-2022

Reason for recall

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

FDA-determined cause: Process change control

Action taken

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.