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Terminated

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

FDA Recall Z-1848-2014 · Posted 2014-06-23

Recalling FirmSteriGear, LLC
Recall StatusTerminated
Product CodeFCN
Date Initiated2011-01-11
Date Terminated2015-01-02
Product Quantity110,560

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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