Recall Z-2958-2018— Covidien LLC

Name: FDA recall Z-2958-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-26

Class II · Ongoing

Class II FDA medical device recall by Covidien LLC, initiated 2018-07-26. It names one FDA 510(k) clearance: K072286. 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: Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.

Recalling firm: Covidien LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-07-26
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISXAspect Medical Systems, Inc.·cleared 2007-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.