Device product
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Z-1450-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4673
- Official record key
device-enforcement:Z-1450-2017
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: RST2391 2018-09 RST2394 2018-09 RST2395 2018-09 RST2406 2018-12 RST2407 2018-12 RST2414 2019-02 RST2415 2019-02 RST2421 2019-03 RST2422 2019-03 RST2429 2019-04 RST2430 2019-04 RST2435 2019-05 RST2445 2019-07 RST2446 2019-07 RST2451 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