FDAClass IDecember 15, 2021

Puritan Bennett 980 Series Ventilator recall

Puritan Bennett 980 Series Ventilator, 980S1ENDICU

Why was Puritan Bennett 980 Series Ventilator recalled?

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

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?

GTIN/UDI - 10884521171114 Serial Numbers: 35B1700409 35B1700443 35B1700457 35B1700462 35B1700473 35B1700476 35B1700483 35B1700487 35B1700490 35B1700511 35B1700552 35B1700567 35B1700569 35B1700570

Product
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Recalling firm
Covidien Llc
Quantity
278 total
Distribution
Worldwide distribution - US Nationwide.
Recall date
December 15, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls