Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN/UDI - 10884521171244 Serial Numbers: 35B1700406 35B1700449 35B1700467 35B1700469 35B1700471 35B1700474 35B1700481 35B1700526 35B1700558
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Covidien Llc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Product Codes/Lot Numbers:
GTIN/UDI - 10884521171244 Serial Numbers: 35B1700406 35B1700449 35B1700467 35B1700469 35B1700471 35B1700474 35B1700481 35B1700526 35B1700558
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0341-2022
Related Recalls
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Due to customer complaint regarding incorrect display box labeling.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.