SteriGear, LLC: Medical Device Recall in 2014 - (Recall #: Z-1848-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 11, 2011

Date Posted: July 2, 2014

Recall Number: Z-1848-2014

Event ID: 68456

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.

Status: Terminated

Product Quantity: 110,560

Code Information:

UPD 851616002007, Part 10270

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated