FDA Enforcement
Class II
Ongoing
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Recall: Z-0320-2022
·
Reported December 8, 2021
Enforcement
- Recall Number
- Z-0320-2022
- 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 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Reason
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Code Info
GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023
Distribution
US Nationwide distribution.