Recall Z-1848-2014— SteriGear, LLC
Class II · Terminated
Class II FDA medical device recall by SteriGear, LLC, initiated 2011-01-11, terminated 2015-01-02. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- SteriGear, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-01-11
- Terminated
- 2015-01-02
- Firm location
- Provo, UT, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.