FDA recall Z-2007-2020
Edwards Lifesciences, LLC · Class II · device
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Reason for recall
Sterile catheter kit packaging compromised.
Distribution
US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Key facts
- Status
- Terminated
- Initiation date
- 2020-03-27
- Report date
- 2020-05-20
- Termination date
- 2021-04-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Irvine, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2007-2020