FDAFDA · Food and drugs·Recall number Z-1450-2017
LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Published March 22, 2017 · Recall initiated: February 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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