Summary
The FDA issued a Class I for Puritan Bennett 980 Series Ventilator, 980X1ENDIUU 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-0347-2022
Action Date
2021-12-15
Status
Terminated
Category
device
Product Description
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Lot/Code Info: GTIN/UDI - 10884521171541 Serial Numbers: 35B1700300 35B1700306 35B1700307 35B1700362 35B1700372 35B1700384 35B1700387 35B1700388 35B1700396 35B1700397 35B1700403 35B1700413 35B1700416 35B1700418 35B1700426 35B1700431 35B1700434 35B1700440 35B1700445 35B1700451 35B1700452 35B1700453 35B1700459 35B1700461 35B1700464 35B1700468 35B1700472 35B1700477 35B1700478 35B1700479 35B1700480 35B1700484 35B1700485 35B1700494 35B1700495 35B1700496 35B1700501 35B1700502 35B1700503 35B1700504 35B1700534 35B1700574 35B1700579 35B1700604 35B1700609 35B1700638 35B1700655 35B1700664 35B1700816 35B1700919 35B1700994 35B1701001 35B1701418 35B1701698 35B1702832 35B1703438 35B1800033 35B1800721 35B1800811
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-0347-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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