Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1848-2014 — 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

U.S. FDA — Device Enforcement · United States · 2011-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1848-2014
Date of alert
2011-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SteriGear, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
851616002007
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.