FDAClass IISeptember 5, 2018

Li-ion battery packs used in BIS Vista and BIS View recall

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

Why was Li-ion battery packs used in BIS Vista and BIS View recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batteries with date code 3114 or older (Week 31 of 2014)

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
Recalling firm
Covidien LLC
Quantity
BIS 46,961; Spare Batteries: 6,937
Distribution
Nationwide Foreign: Australia, New Zealand
Recall date
September 5, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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