Device product
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
Z-1446-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4673
- Official record key
device-enforcement:Z-1446-2017
Official wording
Reason: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Code information: Lot Number/Ex p. Date: RST2390 2018-08 RST2393 2018-09 RST2396 2018-10 RST2397 2018-10 RST2398 2018-10 RST2401 2018-12 RST2402 2018-12 RST2418 2019-02 RST2420 2019-03 RST2423 2019-03 RST2428 2019-04 RST2432 2019-04 RST2433 2019-04 RST2437 2019-06 RST2438 2019-06 RST2441 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