Reported Jan 6, 2021 · Terminated
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen…
Westmed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Westmed, Inc. · 5580 S Nogales Hwy Ste 170 · Tucson, AZ · 85706-3333
Is this the product you have?
REF 0562Adult Elongated O2/CO2 Mask10'X0.50 GSL w/ Swivel Elbow2" Pigtail w/Female Luer Connectors7' Oxygen Supply TubingRx OnlyCE0482(01)00709078001697 -
- Product Usageintended to connect with an oxygen source to deliver oxygen therapy to the patient
- Lot codes and dates
- Lot # 090820N30
- Amount recalled
- 6000 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
This product could cause temporary or reversible health problems — stop using it.
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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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