FDAFDA · Food and drugs·Recall number Z-1481-2015
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Published April 29, 2015 · Recall initiated: April 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Catheter Research, Inc
- Distributor
- Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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