Device product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Z-2007-2020
Product summary
- Event
- Event 85483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 597 units
- Official record key
device-enforcement:Z-2007-2020
Official wording
Reason: Sterile catheter kit packaging compromised.
Code information: Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
Distribution pattern: US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Derived failure modes
-
Sterility assurance
Sterile catheter kit packaging compromised