Summary
The FDA issued a Class I for Puritan Bennett 980 Series Ventilator, 980X3JADIJJ by Covidien Llc. Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during.
Details
Source
Device Recall
External ID
Z-0353-2022
Action Date
2021-12-15
Status
Terminated
Category
device
Product Description
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
Lot/Code Info: GTIN/UDI - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002
Quantity Affected: 278 total
Reason for Recall
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-04
Company
Mansfield, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 144 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien Llc have FDA actions?
Covidien Llc has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0353-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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