FDA Enforcement
Class II
Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
Recall: Z-0382-2016
·
Reported December 16, 2015
Enforcement
- Recall Number
- Z-0382-2016
- Event ID
- 72534
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- LeMaitre Vascular, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 16, 2015
- Initiation Date
- October 21, 2015
- Classification Date
- December 4, 2015
- Termination Date
- July 12, 2019
- Address
- 63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States
Description
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
Reason
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Code Info
Lot Numbers: OTW3079 OTW3079 OTW3046¿ ¿
Distribution
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.
Quantity
4315 total