Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.
- 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:
- Integra LifeSciences Corp.
- Reason for Recall:
- Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Product Codes/Lot Numbers:
Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.
Distribution:
Distributed in: US, CA, DC, FL, IL, IN, MI, MN, NC, NY, PA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0201-2015
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