Labeling is as follows recallZ-1077-05 · Argon Medical Devices, Inc · initiated Jun 27, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1077-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 27, 2005
- Posted by the FDA
- Aug 3, 2005
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 160 kits
- Product code
- IZI
- FDA submissions
- K911732
- Distribution
- TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS
Product description
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***''
Code information (models, lots, serial numbers)
Reorder #: 00-194902A - Lot #: 99444872
Other devices under the same FDA submission
1 device cleared under K911732 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Control Syringe 193210Argon Medical Devices, Inc. · System, X-Ray, Angiographic4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 32510).
- Z-1076-05 · TerminatedProduct consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10…
- Z-1078-05 · TerminatedProduct consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***RE…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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