Z-1848-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- January 11, 2011
- Termination Date
- January 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110,560
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
UPD 851616002007, Part 10270