FDA-Device2017-08-23Class II
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Boston Scientific Corporation
Hazard
Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
Sold states
Worldwide
Affected count
305,779 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3043-2017Don't want to check this manually?
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