FDAClass IIJune 10, 2020

Cardiovascular Monitoring Device accessory - Product recall: Labeling Error

Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or…

Why was Cardiovascular Monitoring Device accessory - Product recalled?

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

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?

Every lot distributed since 1996 with model/catalog number: BSM43-0752-05 (Part number 0600-1005 is on the device label, but 0600-1005 is the non-sellable part of the sellable Toshiba part number BSM43-0752-05).

Product
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or…
Recalling firm
Philips North America, LLC
Quantity
2360 Units
Distribution
US Nationwide distribution.
Recall date
June 10, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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