CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Urinary Drain Bag with Fig Leaf Cover recalled by SteriGear
SteriGear is recalling SteriGear Urinary Drain Bag with Fig Leaf Cover, distributed nationwide in the US. The recall was initiated on 11 Jan 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1848-2014
- FDA event ID
- 68456
- Recalling firm
- SteriGear, Provo, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2011
- FDA classified
- 23 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2011 | Recall initiated by company | |
| 23 Jun 2014 | Classified by FDA | +1259 days |
| 2 Jul 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Urinary Drain Bag with Fig Leaf Cover recalled?
Yes. SteriGear recalled Urinary Drain Bag with Fig Leaf Cover on 11 Jan 2011. The recall is Class II and its status is Terminated. Recall number Z-1848-2014.
Why was it 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.
Which lots are affected?
UPD 851616002007, Part 10270
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |