Z-1081-05

Labeling is as follows: Product labeling: ''Argon Medical DevicesRE-ORDER NO./REF 193248***12cc Control...

Name: Z-1081-05 Labeling is as follows: Product labeling: ''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control...
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***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device... 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-1081-05
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***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for the administraion and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***STERILE EO***STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***Argon Medical Devices, Inc. 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: 34 syringes
Distribution: TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Product codes and lots: Reorder #: 00-193248 - Lot #: 99444008

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)