Summary
The FDA issued a Class I for Puritan Bennett 980 Series Ventilator, 980X1JADIJJ 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-0349-2022
Action Date
2021-12-15
Status
Terminated
Category
device
Product Description
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Lot/Code Info: GTIN/UDI - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026
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-0349-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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