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

Recall Z-1389-2016 — Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

U.S. FDA — Device Enforcement · United States · 2016-03-17 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1389-2016
Date of alert: 2016-03-17
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Cygnus Medical
Product category: device
Product type: Devices

Reported risk: Foreign material in container

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-1389-2016 — Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

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