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Recall Observatory FDA recall evidence

Device product

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU) REF# 2401-52

Z-1451-2017

February 07, 2017

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 76476
Status
Terminated
Classification
Class II
Quantity
247
Official record key
device-enforcement:Z-1451-2017

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: RST2394 2018-09 RST2411 2019-01 RST2412 2019-01 RST2459 2019-10

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

    reason.no_named_rule · v1.0.0

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