Z-1481-2015 Class II Terminated
FDA device recall Z-1481-2015 was initiated by Catheter Research, Inc on April 7, 2015 and is designated Class II. Reason for recall: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa. The recall status is terminated (terminated July 17, 2015). Affected quantity: 880 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2015
- Initiation Date
- April 7, 2015
- Termination Date
- July 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 880 units
Product Description
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Reason for Recall
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Distribution Pattern
Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
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)