Z-1450-2017 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
4673

Product Description

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

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/Exp. Date: RST2391 2018-09 RST2394 2018-09 RST2395 2018-09 RST2406 2018-12 RST2407 2018-12 RST2414 2019-02 RST2415 2019-02 RST2421 2019-03 RST2422 2019-03 RST2429 2019-04 RST2430 2019-04 RST2435 2019-05 RST2445 2019-07 RST2446 2019-07 RST2451 2019-08