Z-1848-2014Class II

SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S...

Name: Z-1848-2014 SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S...
Creator: SteriGear, LLC
Published: 2011-01-11
License: https://open.fda.gov/license/

SteriGear, LLC / initiated 2011-01-11 / Terminated / root cause: design

FDA source

SteriGear, LLC began a recall of 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... on 2011-01-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1848-2014
Classification: Class II
Status: Terminated
Initiated: 2011-01-11
Posted: 2014-06-23
Terminated: 2015-01-02
Recalling firm: SteriGear, LLC
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
Product code: FCN Urinary Drainage Collection Kit, For 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.
Root cause tag: design
FDA 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 in commerce: 110,560
Distribution: Nationwide Distribution
Product codes and lots: UPD 851616002007, Part 10270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1848-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-23

Product code FCN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)