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

Recall Z-0861-2015 — UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

U.S. FDA — Device Enforcement · United States · 2014-10-31 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0861-2015
Date of alert: 2014-10-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: US Endoscopy Group Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00913410

Reported risk: Packaging non-conformance related to the integrity of the sterile pouch seal.

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.

Recall Z-0861-2015 — UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

Related