Z-3043-2017 Class II Terminated
FDA device recall Z-3043-2017 was initiated by Boston Scientific Corporation on June 15, 2017 and is designated Class II. Reason for recall: Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. The recall status is terminated (terminated July 22, 2020). Affected quantity: 305,779 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 23, 2017
- Initiation Date
- June 15, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305,779 units
Product Description
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 Pattern
Worldwide
Code Information
Serial Numbers: (a) 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051, 20127928, 20159518, 20202728, 20206930, 20242335, 20285571, 20309573, 20309574, 20336380, 20394218, 20423644, 20423645, 20456071, 20481170, 20534557 (b) 19640750, 19667072, 19704551, 19755302, 19755307, 19785021, 19808183, 20030825, 20060033, 20087896, 20117909, 20159601, 20171449, 20206929, 20233700, 20256035, 20279769, 20303751, 20336385, 20336386, 20364928, 20364929, 20364930, 20423650, 20472532, 20493563, 20507373, 20534581 (c) 20157078, 19623019, 19755304, 20056496, 20146417, 20264032, 20456079 (d) 19594194, 19717352, 19808180, 20121252, 20223176, 20336387, 20394350, 20534582