Invacare PerfectO2 V Oxygen Concentrator- intended for recall
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US)…
Why was Invacare PerfectO2 V Oxygen Concentrator- intended for recalled?
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249
- Product
- Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US)…
- Recalling firm
- Invacare Corporation
- Quantity
- 384,767 units
- Distribution
- Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
- Recall date
- December 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)