Z-1380-2023 Class II Ongoing
FDA device recall Z-1380-2023 was initiated by Edwards Lifesciences, LLC on February 14, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 326 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- February 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 326 units
Product Description
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
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.
Distribution Pattern
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
Code Information
Primary DI Number: 00690103146998/ Lot: 64526520