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Terminated

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

FDA Recall Z-1452-2017 · Posted None

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2017-02-07
Date Terminated2019-09-20
Product Quantity2065

Reason for Recall

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

Firm Action

LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.

Root Cause

Labeling design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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