Device product
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Z-1556-2022
Product summary
- Event
- Event 90622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-1556-2022
Official wording
Reason: Outer carton packaging of microcatheters were exposed to wet substance during transport.
Code information: Lot # B177543 UDI: (00) 847536006270
Distribution pattern: US Nationwide Distribution: None OUS: Brazil
Derived failure modes
-
Unknown
Outer carton packaging of microcatheters were exposed to wet substance during transport.