Boston Scientific Corporation Recall 88991
Description: HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Boston Scientific Corporation Recall 88991 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0326-2022 |
Event ID | 88991 |
Event Description | HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950 |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Recall Reason | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
Device Classification | 20211208 |
Device 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 |
Center Classification Date | 20211201 |
Recall Initiation Date | 20211021 |
Recalling Firm | Boston Scientific Corporation |
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