FDAClass IDecember 15, 2021

Puritan Bennett 980 Series Ventilator recall

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

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 - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663

Product
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
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