Recall Z-1020-05 ยท MNB Device, Thermal Ablation, Endometrial
Boston Scientific Marlbourgh
Adapter for ACMI Hysteroscope Catalog Number: 55035
| Date | Jul 19, 2005 (initiated Jul 28, 2005) |
| Status | Terminated |
| Reason | The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak. |
| Root cause | Other |
| Action | Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions |
| Distribution | CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.