Recall Z-1079-05 ยท IZI System, X-Ray, Angiographic
Argon Medical Devices, Inc
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***NO
| Date | Aug 3, 2005 (initiated Jun 27, 2005) |
| Status | Terminated |
| Reason | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. |
| 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 | 700 syringes |
| Distribution | TN, IL, WI, MA, VA, IN, LA, TX, CA, JAPAN, GERMANY, THE NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.