Z-1169-2021 Class II Ongoing
FDA device recall Z-1169-2021 was initiated by Boston Scientific Corporation on January 19, 2021 and is designated Class II. Reason for recall: Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. The recall status is ongoing. Affected quantity: 335,788 units total (Domestic: 222,882, Foreign: 112,906).
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335,788 units total (Domestic: 222,882, Foreign: 112,906)
Product Description
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
Reason for Recall
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Distribution Pattern
US nationwide distribution.
Code Information
Outer box GTIN: 08714729855934 Inner pouch GTIN: 08714729861263 Lot/Batch#: 25053639 Outer box GTIN: 08714729855903 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24948407, 24670592, 24679619, 24676929, 24939628 Outer box GTIN: 08714729861300 Inner pouch GTIN: 087147298 61294 Lot/Batch#: 24770325, 24952552, 24665104 Outer box GTIN: 08714729861317 Inner pouch GTIN: 08714729861294 Lot/Batch#: 24679614, 25054403 Outer box GTIN: 08714729861348 Inner pouch GTIN: 08714729861324 Lot/Batch#: 24772995