FDA recall Z-2958-2018

Covidien LLC · Class II · device

Product

Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

Reason for recall

Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Distribution

Nationwide Foreign: Australia, New Zealand

Key facts

Status
Ongoing
Initiation date
2018-07-26
Report date
2018-09-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2958-2018