Recall Z-1848-2014 ยท FCN Urinary Drainage Collection Kit, For Indwelling Catheter
SteriGear, LLC
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
| Date | Jun 23, 2014 (initiated Jan 11, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | SteriGear, LLC sent a special note to all affected customers between January 12, 2011 and September 28, 2012. The note identified the product, the problem, and the action to be taken by the customer. Customers were instructed on how to reposition the inlet tube. Customers with questions were instructed to contact Director of Product Development at 801-607-3211. No correction or removal was performed. For questions regarding this recall call 801-607-3209. |
| Quantity | 110,560 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.