FDA recall Z-1396-2022

Product

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

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.

Key facts

Status

Completed

Initiation date

2022-06-02

Report date

2022-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Leeds, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2022