FDA recall Z-3043-2017

Product

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

Reason for recall

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

Distribution

Worldwide

Key facts

Status

Terminated

Initiation date

2017-06-15

Report date

2017-08-23

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3043-2017