SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml… recallZ-1848-2014 · SteriGear, LLC · initiated Jan 11, 2011
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SteriGear, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1848-2014
- Status
- Terminated
- Initiated by the company
- Jan 11, 2011
- Posted by the FDA
- Jun 23, 2014
- Recalling firm
- SteriGear, LLC
- Quantity
- 110,560
- Product code
- FCN
- Distribution
- Nationwide Distribution
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
Code information (models, lots, serial numbers)
UPD 851616002007, Part 10270
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SteriGear A4092-81Sterigear, LLC · Urinary drainage collection kit, for indwelling catheter1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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