Z-0757-2021 Class II Ongoing
FDA device recall Z-0757-2021 was initiated by Boston Scientific Corporation on November 16, 2020 and is designated Class II. Reason for recall: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. The recall status is ongoing. Affected quantity: 458 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 16, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 458 units
Product Description
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Reason for Recall
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Distribution Pattern
Distribution US nationwide and Japan.
Code Information
GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.