Reported Dec 15, 2021 · Terminated
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
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 Ventilator980X3ENDIUU
- Lot codes and dates
- GTIN/UDI - 10884521172524
- Serial Numbers
82 of 82 codes
35B170030835B170031135B170036135B170036335B170036435B170036635B170036835B170036935B170037035B170037135B170037335B170037535B170037635B170037735B170037835B170037935B170038035B170038235B170038335B170038535B170038635B170038935B170039035B170039135B170039235B170039435B170039535B170039835B170040035B170040135B170040235B170040435B170041035B170041435B170041535B170041735B170042135B170042235B170042335B170042435B170043335B170044135B170044435B170044635B170044835B170045035B170045435B170045535B170046335B170046635B170049135B170049735B170049835B170050035B170050635B170051535B170052135B170052335B170052435B1700528
- 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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