—#40216

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***''

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K911732
Affected lot / code info: Reorder #: 00-194902A - Lot #: 99444872

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS

Timeline

Recall initiated: 2005-06-27
Posted by FDA: 2005-08-03
Terminated: 2007-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40216. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.