Warning
SurgiSmoke Solutions Recalls Flamingo Funnel Large
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1926-2026Medical Device
SurgiSmoke Solutions Recalls Flamingo Funnel Large
SurgiSmoke Solutions · Class II — Moderate Risk
Product Description
Flamingo Funnel Large, Model Number SQ20012-03
Reason for Recall
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database