Device product
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
Z-0389-2016
Product summary
- Event
- Event 72534
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4315 total
- Official record key
device-enforcement:Z-0389-2016
Official wording
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Code information: Lot Number: NSE1663
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
compromised sterility