Z-1079-05

Labeling is as follows: Product Labeling: ''Argon Medical DevicesMANIFOLD KIT***SINGLE USE...

Name: Z-1079-05 Labeling is as follows: Product Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE...
Creator: Argon Medical Devices, Inc
Published: 2005-06-27
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2005-06-27 / Terminated

FDA source

Argon Medical Devices, Inc began a recall of Labeling is as follows: Product Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION... on 2005-06-27. The reason FDA records is "The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1079-05
Status: Terminated
Initiated: 2005-06-27
Posted: 2005-08-03
Terminated: 2007-04-19
Recalling firm: Argon Medical Devices, Inc
Product: Labeling is as follows: Product Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or repacking.***1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***Quantity: 20 ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide) Sterilization Recommended***1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
Product code: IZI System, X-Ray, Angiographic
Reason for recall: The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
FDA root cause: Other
Action: The firm plans to distribute recall letters to all customers indicated on the customer list. TELEPHONE 6/27/2005. All products will be returned to Argon and disposed.
Quantity in commerce: 700 syringes
Distribution: TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Product codes and lots: Reorder #: 00-094337 - Lot #: 99442306 Reorder #: 00-094367 - Lot #: 99443999 Reorder #: 00-094367 - Lot #: 99444179

Product code IZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)