FDA Enforcement
Class II
Ongoing
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Recall: Z-0322-2022
·
Reported December 8, 2021
Enforcement
- Recall Number
- Z-0322-2022
- 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 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Reason
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code Info
GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
Distribution
US Nationwide distribution.