Z-1452-2017 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
2065

Product Description

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-53

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: RST2392 2018-09 RST2400 2018-10 RST2408 2018-12 RST2419 2019-04 RST2431 2019-04 RST2436 2019-05 RST2447 2019-08