FDA-Device2014-07-02Class II
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
SteriGear, LLC
Hazard
SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
Sold states
Nationwide Distribution
Affected count
110,560
Manufactured in
362 S University Ave, N/A, Provo, UT, United States
Products
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1848-2014Don't want to check this manually?
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