Reported Dec 15, 2021 · Terminated
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Covidien LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
Puritan Bennett 980 Series Ventilator980X1ENDIUU
- Lot codes and dates
- GTIN/UDI - 10884521171541
- Serial Numbers
35B170030035B170030635B170030735B170036235B170037235B170038435B170038735B170038835B170039635B170039735B170040335B170041335B170041635B170041835B170042635B170043135B170043435B170044035B170044535B170045135B170045235B170045335B170045935B170046135B170046435B170046835B170047235B170047735B170047835B170047935B170048035B170048435B170048535B170049435B170049535B170049635B170050135B170050235B170050335B170050435B170053435B170057435B170057935B170060435B170060935B170063835B170065535B170066435B170081635B170091935B170099435B170100135B170141835B170169835B170283235B170343835B180003335B180072135B1800811
- Amount recalled
- 278 total
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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