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U.S. Department of Health and Human Services

Class 2 Device Recall HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray Shapeable

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  Class 2 Device Recall HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray Shapeable see related information
Date Initiated by Firm April 07, 2015
Date Posted April 21, 2015
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-1481-2015
Recall Event ID 70948
510(K)Number K032835  
Product Classification Catheter, intrauterine and introducer - Product Code HGS
Product HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
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)
Recalling Firm/
Manufacturer		 Catheter Research, Inc
5610 W 82nd St
Indianapolis IN 46278-1300
For Additional Information Contact Babacar Diouf
317-872-0074
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
Action Catheter Research, Inc. (CRI) has initiated a voluntary medical device removal of HSG Tray/ 5F HS Catheter Combo, and issued letters to customer son 04/07/2015 by e-mail and certified mail. Customers are asked to inspect their inventory and return recalled devices to CRI for replacement. If the devices were further distributed CRI requested customers provide notice of the recall. Customers may contact Babacar Diouf, VP of RA and QS, at (317) 872-0074 ext. 3512.
Quantity in Commerce 880 units
Distribution Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGS and Original Applicant = CATHETER RESEARCH, INC.
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