FDA-Device2021-03-10Class II
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.
Boston Scientific Corporation
Hazard
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Sold states
US nationwide distribution.
Affected count
335,788 units total (Domestic: 222,882, Foreign: 112,906)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2021Don't want to check this manually?
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