SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction
SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (urinary retention/pressure issues) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
SteriGear, LLC is recalling 110,560 units of the SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml (REF 10270). The product is a sterile urinary drainage collection kit intended for use with indwelling catheters. The recall is due to a defect where the drain bag valve can close, creating negative pressure that can suck the non-return valve closed.
This issue may prevent the proper drainage of urine from the catheter. The affected units were distributed nationwide. The specific product code is UPD 851616002007, Part 10270.
Consumers and healthcare facilities should stop using the affected drain bags and contact SteriGear for further instructions or a replacement. The company has notified customers of the circumstances surrounding this defect.
The recalled product
- Product
- 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…
- Manufacturer
- SteriGear, LLC
- Affected units
- 110,560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UPD 851616002007
- Part 10270
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · valve malfunction
See all →- ModerateNitrous Oxide Cartridges Recalled Due to Premature Valve Opening
FDA (Devices) · 2025-02-12
- HighInfusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow
FDA (Devices) · 2024-07-24
- HighIV Infusion Pump Sets Recalled for Backcheck Valve Malfunction
FDA (Devices) · 2024-07-24
- HighInfusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction
FDA (Devices) · 2024-07-24
- HighInfusomat SPACE IV infusion sets recalled for backcheck valve malfunction
FDA (Devices) · 2024-07-24
Similar recalls
- HighDover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
- ModerateBard Urinary Drainage Bags Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2015-04-08
- HighDover Urinary Catheter Drainage Bag Port Occlusion Recall
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14