Recall Z-1396-2022— Surgical Innovations Ltd

Name: FDA recall Z-1396-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-02

Class II · Completed

Class II FDA medical device recall by Surgical Innovations Ltd, initiated 2022-06-02. It names one FDA 510(k) clearance: K190592. Product: YelloPort Elite Universal Seal. For use in laparoscopic procedures.. Reason: There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product..

Recalling firm: Surgical Innovations Ltd
Classification: Class II
Status: Completed
Initiated: 2022-06-02
Firm location: Leeds, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K190592 — YelloPort Elite Port Access SystemSurgical Innovations Limited·cleared 2019-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.