YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Summary
The FDA issued a Class II for YelloPort Elite Universal Seal. For use in laparoscopic procedures. by Surgical Innovations Ltd. Reason: There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product..
Details
Source
Device Recall
External ID
Z-1396-2022
Action Date
2022-07-27
Status
Completed
Category
device
Product Description
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
Lot/Code Info: All Lots; UDI/DI:05051986001562
Quantity Affected: N/A
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-02
Company
Leeds, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Surgical Innovations Ltd has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Surgical Innovations Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Surgical Innovations Ltd have FDA actions?
Surgical Innovations Ltd has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1396-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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