Z-1444-2017 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
608

Product Description

LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU) REF # e2400-52

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/Ex Date: RED1746 2018-09 RED1753 2018-12 RED1762 2019-03 RED1765 2019-03 RED1779 2019-09