| Class 2 Device Recall HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray Shapeable | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HGS
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