FDAClass IIJune 10, 2015

Smiths Medical recall

Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.

Why was Smiths Medical recalled?

The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in data formatting issues or incorrect data being transmitted in or out of the serial port into a data collection system.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Serial Numbers: 4059587 through 4059591 UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960

Product
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Recalling firm
Smiths Medical ASD, Inc.
Quantity
5 UPDATE 4-20-2015 to include 10 additional devices
Distribution
MN
Recall date
June 10, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls