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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 1417696
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- US Endoscopy Group Inc
- Reason for Recall:
- Packaging non-conformance related to the integrity of the sterile pouch seal.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot 1417696
Distribution:
Distributed in: FL, MO, OH, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0861-2015
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