Z-1077-05

Labeling is as follows: Product Labeling: ''Argon Medical DevicesCUSTOM MANIFOLD KIT***REF/REORDER NO...

Name: Z-1077-05 Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO...
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***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1... 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-1077-05
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***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing Set***1 Zero Port Plug, Serrated***1 Monitor Line Labels***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***'' Carton Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***Quantity: 10 ea***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***''
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: 160 kits
Distribution: TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Product codes and lots: Reorder #: 00-194902A - Lot #: 99444872

Product code IZI

K911732Class IIAdvance Disposable Control SyringeAdvance Medical Designs, Inc. / cleared 1991-09-16

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)