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Boston Scientific Corporation recalls Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN:
Recalled March 10, 2021 · FDA recall Z-1168-2021 · 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 Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →