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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