Z-1848-2014 Class II Terminated
FDA device recall Z-1848-2014 was initiated by SteriGear, LLC on January 11, 2011 and is designated Class II. 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. The recall status is terminated (terminated January 2, 2015). Affected quantity: 110,560.
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