FDAFDA · Food and drugs·Recall number Z-1848-2014
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
Published July 2, 2014 · Recall initiated: January 11, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SteriGear, LLC
- Distributor
- Nationwide Distribution
- Lot
- UPD 851616002007, Part 10270
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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