Z-1739-2010

CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon...

Name: Z-1739-2010 CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon...
Creator: Argon Medical Devices, Inc
Published: 2010-03-29
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2010-03-29 / Terminated / root cause: packaging

FDA source

Argon Medical Devices, Inc began a recall of CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX... on 2010-03-29. The reason FDA records is "There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to...". 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-1739-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-06-02
Terminated: 2010-07-29
Recalling firm: Argon Medical Devices, Inc
Product: CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.
Product code: KGC Tube, Gastro-Enterostomy
Reason for recall: There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Argon Medical Devices issued an "Urgent Medical Device Recall" notification via certified mail dated March 29, 2010 to distributors and end users. A Response Form was attached. Consignees were informed of the affected product and asked to quarantine and return all unused product to the firm. For further information, contact Argon Medical Devices at 1-903-677-9375.
Quantity in commerce: 70 kits
Distribution: Distributed to United States (IL, AL, NY, TX, OK, MI, NC, CA, OH, VA, KY, CO, LA, WA, MO, AND IA) and Canada.
Product codes and lots: Catalog Number: 496413Y, Lot Number: 99737884, Expiration Date: 2014-06.

Product code KGC

K781333Class IICentral Catheter TrayArgon Medical Corp. / cleared 1978-10-24

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)