FDAFDA · Food and drugs·Recall number 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.
Published December 31, 2014 · Recall initiated: October 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging non-conformance related to the integrity of the sterile pouch seal.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- US Endoscopy Group Inc
- Distributor
- Distributed to the states of FL, MO, OH and WI.
- Lot
- Lot 1417696
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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