Device product
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Z-0387-2016
Product summary
- Event
- Event 72534
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4315 total
- Official record key
device-enforcement:Z-0387-2016
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: SLC3636 SLC3636 (sample) SLC3636¿SLC3668 SLC3668¿SLC3669¿SLC3654¿ SLC3670¿
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