Aesculap AG: AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Hazard

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

Details from the source

Reason for recall: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." Distribution: 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. Quantity: 1 unit Lot/code info: Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.

UPC codes

04046963805777

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.