FDAFDA · Food and drugs·Recall number Z-0379-2016
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Published December 16, 2015 · Recall initiated: October 21, 2015
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
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
- Lot
- Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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