FDA Enforcement
Class II
Ongoing
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Recall: Z-0326-2022
·
Reported December 8, 2021
Enforcement
- Recall Number
- Z-0326-2022
- Event ID
- 88991
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 8, 2021
- Initiation Date
- October 21, 2021
- Classification Date
- December 1, 2021
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States
Description
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Reason
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code Info
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
Distribution
US Nationwide distribution.