Covidien LLC recalls Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identif…

Recall date

July 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2958-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide Foreign: Australia, New Zealand

Why it was recalled

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

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

What was recalled

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