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U.S. Department of Health and Human Services

Class 2 Device Recall The Fig Leaf Drain Bag

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 Class 2 Device Recall The Fig Leaf Drain Bagsee related information
Date Initiated by FirmJanuary 11, 2011
Date PostedJune 23, 2014
Recall Status1 Terminated 3 on January 02, 2015
Recall NumberZ-1848-2014
Recall Event ID 68456
Product Classification Urinary drainage collection kit, for indwelling catheter - Product Code FCN
ProductSteriGear 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
Code Information UPD 851616002007, Part 10270
FEI Number 3007608536
Recalling Firm/
Manufacturer		 SteriGear, LLC
362 S University Ave
Provo UT 84601-4472
For Additional Information ContactJason Needles
801-607-3209
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionSteriGear, 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 Commerce110,560
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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