Device product
LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50
Z-1442-2017
Product summary
- Event
- Event 76476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5601
- Official record key
device-enforcement:Z-1442-2017
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: RED1743 2018-09 RED1744 2018-09 RED1749 2018-10 RED1750 2018-12 RED1751 2018-12 RED1755 2018-12 RED1756 2018-12 RED1757 2019-01 RED1759 2019-02 RED1760 2019-02 RED1761 2019-03 RED1764 2019-03 RED1766 2019-04 RED1767 2019-04 RED1768 2019-05 RED1769 2019-05 RED1771 2019-06 RED1773 2019-07 RED1774 2019-07 RED1775 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