—#40219

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***''

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Reorder #: 00-094337 - Lot #: 99442306 Reorder #: 00-094367 - Lot #: 99443999 Reorder #: 00-094367 - Lot #: 99444179

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 #40219. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.