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Boston Scientific Corporation recalls Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311
Recalled March 10, 2021 · FDA recall Z-1170-2021 · 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/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670; M00562672 (Box 20), M00562670; M00562673 (Box 40), M00562670; M00562691 (Box 5); M00562690; M00562692 (Box 20), M00562690; M00562693 (Box 40), M00562690.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →