Z-1442-2017 Class II Terminated

Recalled by LeMaitre Vascular, Inc. — Burlington, MA

Recall Details

Product Type
Devices
Report Date
March 22, 2017
Initiation Date
February 7, 2017
Termination Date
September 20, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5601

Product Description

LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50

Reason for Recall

The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch

Distribution Pattern

Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK

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