Z-0320-2022 Class II Ongoing
FDA device recall Z-0320-2022 was initiated by Boston Scientific Corporation on October 21, 2021 and is designated Class II. Reason for recall: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure The recall status is 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 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
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
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