Z-0326-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Reason for Recall
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Distribution Pattern
US Nationwide distribution.
Code Information
Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023