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SteriGear, LLC recalls SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, p
Recalled July 2, 2014 · FDA recall Z-1848-2014 · SteriGear
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. · FDA Class II
Units
110,560
Sold at
Nationwide Distribution
Description
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.
Product
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
Manufacturer(s)
SteriGear, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →