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Puritan Bennett recallZ-0350-2022 · Covidien Llc · initiated Nov 4, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Reprocessing Controls

What the company is doing

On November 4, 2021, the firm began to notify customers through Urgent Medical Device Correction letters. Customers were informed of the device defect that may lead to the ventilator becoming inoperable during use. Actions you should take Immediately discontinue use of the affected ventilators. Remove the affected ventilators from clinical service and quarantine the affected ventilators until such time that a Medtronic Technical Service Engineer inspects and replaces the affected printed circuit board assemblies. Notify all personnel in all care environments in which the affected PB980 series ventilators are used about this medical device correction. If your facility has distributed affected PB980 series ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. If you are aware of any incidents related to this issue, please contact our Technical Support Department immediately at 1-800-255-6774, option 4, and then option 1 to provide information regarding those events so regulatory reporting obligations can be fulfilled. Work with the Medtronic Technical Support Department if you require assistance finding alternative ventilation devices. Beginning November 5, 2021, Medtronic Technical Service will contact all affected customers to schedule a service appointment for all potentially affected ventilators. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.

Recall details

Recall number
Z-0350-2022
Status
Terminated
Initiated by the company
Nov 4, 2021
Posted by the FDA
Dec 9, 2021
Recalling firm
Covidien Llc
Quantity
278 total
Product code
CBK
FDA submissions
K193056
Distribution
Worldwide distribution - US Nationwide.

Product description

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

Code information (models, lots, serial numbers)

GTIN/UDI - 10884521171619 Serial Numbers: 35B1700425 35B1700438 35B1700458 35B1700460 35B1700656 35B1700659 35B1700660

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 88987).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page