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Boston Scientific Corporation recalls Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00
Recalled March 10, 2021 · FDA recall Z-1169-2021 · Boston Scientific
Hazard
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. · FDA Class II
Units
335,788 units total (Domestic: 222,882, Foreign: 112,906)
Sold at
US nationwide distribution.
Description
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Product
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →