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Surgical Innovations Ltd recalls YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Recalled July 27, 2022 · FDA recall Z-1396-2022 · Surgical Innovations
Hazard
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product. · FDA Class II
Units
N/A
Sold at
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.
Description
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Product
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Manufacturer(s)
Surgical Innovations Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →