LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-51
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- February 7, 2017
- Terminated
- September 20, 2019
- Recall Number
- Z-1448-2017
- Quantity
- 2065
- 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: RST2403 2018-12 RST2409 2019-01 RST2410 2019-01 RST2427 2019-03 RST2434 2019-05 RST2439 2019-06 RST2444 2019-07
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.