Z-1396-2022 Class II
FDA device recall Z-1396-2022 was initiated by Surgical Innovations Ltd on June 2, 2022 and is designated Class II. 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. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 2, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
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.
Distribution Pattern
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, Malaysia, Mexico, N. Ireland, Norway, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and Dubai.
Code Information
All Lots; UDI/DI:05051986001562