Device product
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
Z-1448-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2065
- Official record key
device-enforcement:Z-1448-2017
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: RST2403 2018-12 RST2409 2019-01 RST2410 2019-01 RST2427 2019-03 RST2434 2019-05 RST2439 2019-06 RST2444 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