Device product
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU) REF# 2401-50
Z-1447-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 403
- Official record key
device-enforcement:Z-1447-2017
Official wording
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Code information: Lot Number/Exp. Date: RST2404 2018-012 RST2416 2019-02 RST2424 2019-03 RST2426 2019-03 RST2442 2019-07
Distribution pattern: Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Derived failure modes
-
Unknown
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch