LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU) REF# 2401-51
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- February 7, 2017
- Terminated
- September 20, 2019
- Recall Number
- Z-1449-2017
- Quantity
- 179
- Firm Location
- Burlington, MA
Reason for Recall
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Distribution
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Lot / Code Info
Lot Number/Exp. Date: RST2405 2018-12 RST2417 2019-02 RST2425 2019-03 RST2449 2019-08
Root Cause
Labeling design
Action Taken
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.
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