Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085
- 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:
- Edwards Lifesciences, LLC
- Reason for Recall:
- There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
Product Codes/Lot Numbers:
Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1379-2023
Related Recalls
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.