UroSeal Adjustable Endoscopic Valve recall
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5…
Why was UroSeal Adjustable Endoscopic Valve recalled?
Packaging non-conformance related to the integrity of the sterile pouch seal.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1417696
- Product
- UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5…
- Recalling firm
- US Endoscopy Group Inc
- Quantity
- 100 units
- Distribution
- Distributed to the states of FL, MO, OH and WI.
- Recall date
- December 31, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)