Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1848-2014

January 11, 2011

Class II

Product summary

Firm
SteriGear, LLC
Event
Event 68456
Status
Terminated
Classification
Class II
Quantity
110,560
Official record key
device-enforcement:Z-1848-2014

Official wording

Reason: 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.

Code information: UPD 851616002007, Part 10270

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.