Device product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Z-0026-2026
Product summary
- Firm
- Aesculap AG
- Event
- Event 97507
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0026-2026
Official wording
Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Code information: Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
Distribution pattern: US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.
Derived failure modes
-
Labeling or packaging
Mislabeling