Device product
LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
Z-1449-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 179
- Official record key
device-enforcement:Z-1449-2017
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: RST2405 2018-12 RST2417 2019-02 RST2425 2019-03 RST2449 2019-08
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