Device product
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Z-1481-2015
Product summary
- Event
- Event 70948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 880 units
- Official record key
device-enforcement:Z-1481-2015
Official wording
Reason: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Code information: Model Number/Catalogue/Product Number: TMI1160; 61-5205; TMI1198; KM61-5205; 61-3205; Lot codes: J436A, J436B, J436C, J436D; J437A, J437B, J437C, J437D; Exp. J436 (2017-03); J437 (2017-03)
Distribution pattern: Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
Derived failure modes
-
Labeling or packaging
mislabeled