Recall Z-1077-06 ยท LKF Cannula, Manipulator/Injector, Uterine
Catheter Research, Inc
Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.
| Date | Jun 1, 2006 (initiated Apr 24, 2006) |
| Status | Terminated |
| Reason | The uterine stop component was not included with the device. |
| Root cause | Other |
| Action | Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product. |
| Quantity | 660 |
| Distribution | Minnesota and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020292 | UTERINE INJECTOR Catheter Research, Inc., Apr 17, 2002 |