Reported Dec 31, 2014 · Terminated

UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary…

US Endoscopy Group Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: US Endoscopy Group Inc · 5976 Heisley Rd · Mentor, OH · 44060-1873

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot 1417696
Amount recalled
100 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2015 · Data as of Sep 19, 4:48 PM UTC

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