Medical device recalls Moderate risk

Boston Scientific Corporation recalls Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

Recall date
June 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3043-2017
FDA classification
Class II
Brand / firm
Boston Scientific Corporation
Sold / distributed
Worldwide

Why it was recalled

Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

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