Recall Z-1396-2022 ยท GCJ Laparoscope, General & Plastic Surgery
Surgical Innovations Ltd
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
| Date | Jun 2, 2022 |
| Status | Completed |
| Reason | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. |
| Root cause | Process change control |
| Action | 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. |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, IN, WA, MA and the countries of Armenia, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Ecuador, UK, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Ma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190592 | YelloPort Elite Port Access System Surgical Innovations Limited, Apr 29, 2019 |