Z-1481-2015Class II

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and...

Name: Z-1481-2015 HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and...
Creator: Catheter Research, Inc
Published: 2015-04-07
License: https://open.fda.gov/license/

Biomerics / initiated 2015-04-07 / Terminated / root cause: packaging

FDA source

Catheter Research, Inc began a recall of HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use on 2015-04-07. FDA classified it as Class II and gives the reason as "HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1481-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-07
Posted: 2015-04-21
Terminated: 2015-07-17
Recalling firm: Biomerics
Product: HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Product code: HGS Catheter, Intrauterine And Introducer
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.
Root cause tag: packaging
FDA root cause: 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
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1481-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-21

Product code HGS

K032835Class IIH/s Catheter SetCatheter Research, Inc. / cleared 2003-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)