Class II — SteriGear, LLC
| Recalling firm | SteriGear, LLC |
|---|---|
| Registered facility | SteriGear, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 Urine drained from an indwelling catheter |
| Quantity | 110,560 |
| Distribution | Nationwide Distribution |
| Initiated | 2011-01-11 |
| Classified | 2014-06-23 |
| Terminated | 2015-01-02 |
| Recall number | Z-1848-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SteriGear, LLC (Z-1848-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68456/
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