FDAClass IDecember 15, 2021

Puritan Bennett 980 Series Ventilator recall

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

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 - 10884521172524 Serial Numbers: 35B1700308 35B1700311 35B1700361 35B1700363 35B1700364 35B1700366 35B1700368 35B1700369 35B1700370 35B1700371 35B1700373 35B1700375 35B1700376 35B1700377 35B1700378 35B1700379 35B1700380 35B1700382 35B1700383 35B1700385 35B1700386 35B1700389 35B1700390 35B1700391 35B1700392 35B1700394 35B1700395 35B1700398 35B1700400 35B1700401 35B1700402 35B1700404 35B1700410 35B1700414 35B1700415 35B1700417 35B1700421 35B1700422 35B1700423 35B1700424 35B1700433 35B1700441 35B1700444 35B1700446 35B1700448 35B1700450 35B1700454 35B1700455 35B1700463 35B1700466 35B1700491 35B1700497 35B1700498 35B1700500 35B1700506 35B1700515 35B1700521 35B1700523 35B1700524 35B1700528 35B1700532 35B1700535 35B1700550 35B1700556 35B1700571 35B1700607 35B1700620 35B1700666 35B1700989 35B1701004 35B1701015 35B1701417 35B1701419 35B1702698 35B1702873 35B1703371 35B1703383 35B1703421 35B1800480 35B1800511 35B1800522 35B1800531

Product
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
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